Ab externo intraocular shunt placement

ABSTRACT

An intraocular shunt can be placed into the eye in an ab externo approach. A clinician may determine an entry area below a corneal limbus of an eye and a target outflow region. Thereafter, the clinician can insert a hollow shaft into the eye at the entry area toward an anterior chamber of the eye, the shaft carrying an intraocular shunt therein. The clinician can position an inflow end of the shunt within the anterior chamber of the eye and, while maintaining the shunt inflow end in the anterior chamber, can remove the shaft from the eye to release the shunt. Finally, the clinician can repositioning an outflow end of the shunt within the target outflow region and verify placement of the outflow end of the shunt within the target outflow region.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/172,090, filed on Jun. 2, 2016, which claims the benefit of U.S.Patent Application No. 62/279,585, filed on Jan. 15, 2016, and of U.S.Patent Application No. 62/170,338, filed on Jun. 3, 2015, the entiretyof each of which is incorporated herein by reference.

FIELD OF THE INVENTIONS

The present disclosure generally relates to devices and ab externomethods of implanting an intraocular shunt into an eye.

BACKGROUND

Glaucoma is a disease in which the optic nerve is damaged, leading toprogressive, irreversible loss of vision. It is typically associatedwith increased pressure of the fluid (i.e., aqueous humor) in the eye.Untreated glaucoma leads to permanent damage of the optic nerve andresultant visual field loss, which can progress to blindness. Once lost,this damaged visual field cannot be recovered. Glaucoma is the secondleading cause of blindness in the world, affecting 1 in 200 people underthe age of fifty, and 1 in 10 over the age of eighty for a total ofapproximately 70 million people worldwide.

In conditions of glaucoma, the pressure of the aqueous humor in the eye(anterior chamber) increases and this resultant increase of pressure cancause damage to the vascular system at the back of the eye andespecially to the optic nerve. The treatment of glaucoma and otherdiseases that lead to elevated pressure in the anterior chamber involvesrelieving pressure within the anterior chamber to a normal level.

The importance of lowering intraocular pressure (IOP) in delayingglaucomatous progression has been well documented. When drug therapyfails, or is not tolerated, surgical intervention is warranted. Surgicalfiltration methods for lowering intraocular pressure by creating a fluiddrainage pathway between the anterior chamber and an area of lowerpressure have been described. Intraocular shunts can be positioned inthe eye to drain fluid from the anterior chamber to locations such asthe sub-Tenon's space, the subconjunctival space, the episcleral vein,the suprachoroidal space, Schlemm's canal, and the intrascleral space.

Methods of implanting intraocular shunts are known in the art. Shuntsmay be implanted using an ab externo approach (entering through theconjunctiva and inwards through the sclera) or an ab interno approach(entering through the cornea, across the anterior chamber, through thetrabecular meshwork and sclera).

Positioning of an intraocular shunt to drain fluid into the intrascleralspace is promising because it avoids contact with the conjunctiva andthe suprachoroidal space. Avoiding contact with the conjunctiva andchoroid is important because it reduces irritation, inflammation andtissue reaction, which can lead to fibrosis and reduce the outflowpotential of the subconjunctival and suprachoroidal space. Theconjunctiva itself plays a critical role in glaucoma filtration surgery.A less irritated and healthy conjunctiva allows drainage channels toform and less opportunity for inflammation and scar tissue formation.Intrascleral shunt placement safeguards the integrity of the conjunctivaand choroid, but may provide only limited outflow pathways that mayaffect the long term TOP lowering efficacy.

SUMMARY

Traditional ab externo approaches are shown for example in Nissan et al.(U.S. Pat. No. 8,109,896), Tu et al. (U.S. Pat. No. 8,075,511), andHaffner et al. (U.S. Pat. No. 7,879,001), the content of each of whichis incorporated by reference herein in its entirety.

In such traditional surgeries, a distal end of a deployment device orinjector is used to make a scleral flap or slit to access the eye. Theconjunctiva can be dissected or pulled away from the sclera to exposethe sclera. In some instances, this can allow the surgeon to cut andseparate a small flap of the sclera away from the underlying sclera. Aneedle can then be inserted into the eye below the scleral flap toaccess the anterior angle of the eye. The needle is then withdrawn,leaving a scleral slit behind.

Thereafter, a silicone tube with sufficient stiffness is manually pushedthrough the scleral slit from the outside so that the distal tube endsdistal to the trabecular meshwork in the anterior chamber of the eye. Insome instances, the scleral flap can be repositioned over the proximalend of the tube and sutures can be used to re-secure the flap andconjunctiva. In other instances where only the conjunctiva is dissected,the proximal end of the tube can be positioned to exit the sclera, layon top of it, and be connected to a plate that is fixated by sutures tothe outside scleral surface (and within a pocket underlying theconjunctiva) far away (>10 mm) from the limbus.

Some of the problems associated with this surgery include the necessityto cauterize to avoid significant bleeding and the large size of theremaining silicone tube and plate. Due to the obtrusive nature of thesilicone tube and plate, these can eventually cause the conjunctiva toerode, requiring a scleral graft to be placed over the silicone tube andplate.

The present disclosure provides various new methods and device conceptsfor an ab externo implantation of an intraocular shunt, such as a gelshunt. Some embodiments disclosed herein provide an associated injectordocking device for maintaining, securing, or fixing a position of aninjector relative to the eye during eye surgery. One of the aims is tocreate a simple and safe procedure that can be performed in an officesetting. These new ab externo approaches provided by some embodimentscan use a deployment device or injector similar in operation to thecurrent XEN Injector produced by Applicant. Further, these new abexterno approaches can be implemented using the injector by itself or byusing the injector in combination with one or more injector dockingdevices.

According to some embodiments, ab externo procedures are provided hereinthat enable an outflow end of a shunt to be deployed under/into any of avariety of outflow regions without making a scleral flap or otherwiserequiring a conjunctival dissection. Thus, the outflow end of the shuntcan be positioned in target outflow regions including thesubconjunctival space or over-Tenon's space (between Tenon's andconjunctiva), the suprascleral or sub-Tenon's space (between Tenon's andsclera), the intra-Tenon's space (between layers of Tenon's capsule, orin the intra-Tenon's adhesion space), the choroidal and suprachoroidalspace, the intrascleral space (between layers of sclera), Schlemm'scanal, the vitreous space, the episcleral vein, or the supraciliaryspace. According to some embodiments disclosed herein, any of thesetarget outflow regions can be ballooned to create an outflow reservoiror space. As discussed herein, the ballooning can be done via aninjection of a basic salt solution (“BSS”), a viscoelastic, ananti-metabolite, a drug-eluting solution, water, and/or a combinationthereof. Further, in accordance with some embodiments in which theoutflow end of the shunt is placed in the intra-Tenon's adhesion space,the Tenon adhesions remain intact, just as they would for an ab internoapproach. Thus, a needle of a shunt injector can pierce conjunctiva,sclera, and in some embodiments, Tenon's capsule, as it is advanced intothe eye to position the shunt within the eye without creating a scleralflap or conjunctival dissection. For example, the shunt can providefluid communication between the anterior chamber and a desired targetoutflow region.

In accordance with some embodiments, a surgeon can inject a fluid abexterno into the target outflow region to create a bleb in order tofacilitate positioning of an outflow end of a shunt within the targetoutflow region. In some embodiments, the bleb can be created after theshunt is implanted into the eye and the injector is removed. However, insome embodiments, the bleb can be created prior to implantation of theshunt. Further, the bleb can be created prior to implantation of theshunt and reinflated after the shunt has been implanted.

For example, a surgeon can insert a shunt through a bleb such that aninflow or distal end of the shunt is positioned in a region of higherpressure in the eye (e.g., the anterior chamber) and an outflow orproximal end of the shunt is positioned in a region of lower pressure inthe eye (e.g., the outflow proximal end of the shunt is positionedwithin the bleb in the target outflow region). Once the shunt is inposition, the bleb can eventually deflate and collapse against theoutflow end of the shunt, thereby positioning the outflow end of theshunt against the contour of the eye. Thereafter, the shunt can providea drainage pathway from the region of higher pressure to the targetoutflow region.

Advantageously, some embodiments therefore provide methods and devicesthat place an intraocular shunt ab externo into the eye withoutrequiring a low gauge silicone tube or diffusion plate attached to thetube, as used in the prior art. Instead, according to some embodiments,a higher gauge needle and intraocular shunt can be placed withoutcausing significant trauma to the eye. The shunt can be inserted throughthe target outflow region and ejected from the needle such that aninflow end of the shunt resides in the anterior chamber of the eye andan outflow end of the needle resides in the target outflow region.

Moreover, in some embodiments, a surgeon can use an injector dockingdevice to facilitate positioning and maintaining an orientation of theshunt relative to one or more aspects of the eye. The injector dockingdevice can optionally comprise one or more structures that canfacilitate positioning of the injector docking device onto or around theeye. Optionally, the injector docking device can comprise one or morefeatures that can secure the injector docking device relative to the eyeonce a desired position has been achieved. In some embodiments, suchfeatures can be selectively activated once the injector docking deviceis in a desired position. Such features can include vacuum suctionand/or surface friction elements (such as ridges, micro-hooks, or othersuch elements that can increase the surface contact and/or frictionbetween the injector docking device and the eye). In some embodiments,suction and mechanical engagement can be used alone or together toenable the injector docking device to be coupled to or removably affixedto the eye.

Some methods can comprise treatment with a drug or pharmaceutical, suchas by implanting an intraocular shunt that has been coated and/orimpregnated with a pharmaceutical and/or biological agent, by treatingthe eye topically with a pharmaceutical and/or biological agent, and/orby injecting a pharmaceutical and/or biological agent into the anteriorchamber and/or a target outflow region, including any target outflowregions discussed or referenced herein, prior to or after releasing ashunt from the device. Suitable agents may include, for example, any ofthose disclosed in the following U.S. Patent Nos.: 8,785,394; 8,062,657;7,799,336; 7,790,183; 7,033,605; 6,719,991; 6,558,686; 6,162,487;5,902,283; 5,853,745; and 5,624,704; and U.S. Patent Publication No.2008/0108933; the content of each of these references is incorporated byreference herein its entirety. Further examples of suitable agentsinclude anti-mitotic pharmaceuticals such as Mitomycin-C or5-Fluorouracil, anti-VEGF (such as Lucentis, Macugen, Avastin, VEGF orsteroids), anti-coagulants, anti-metabolites, angiogenesis inhibitors,steroids, anti-inflammatories, antibiotics, brimonidine, timolol,prostaglandin analogs (such as travoprost, latanoprost, and tafluprost),prostamides (such as bimatoprost), cyclosporin, pilocarpine,corticosteroids and other steroid derivatives (such as hydrocortisone,dexamethasone, beclomethasone dipropionate, triamcinolone, triamcinoloneacetate, cortisol benzoate), or other agents for treating conditions ofthe eye, such as glaucoma, dry eye, allergy, or conjunctivitis, to namea few.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of illustrative embodiments of the inventions aredescribed below with reference to the drawings. The illustratedembodiments are intended to illustrate, but not to limit, theinventions. The drawings contain the following figures:

FIG. 1 is a cross-sectional diagram of the general anatomy of an eye.

FIG. 2 is an enlarged cross-sectional diagram of the eye taken alonglines 2-2 of FIG. 1 .

FIGS. 3A and 3B illustrate injector docking devices for use with anintraocular shunt injector, according to some embodiments.

FIGS. 4 and 5 illustrate a procedure for implanting an intraocular shuntinto an eye using an injector and the injector docking device shown inFIG. 3A, according to some embodiments.

FIG. 6 is a top perspective view of an injector docking device,according to some embodiments.

FIG. 7 is a bottom perspective view of the injector docking device ofFIG. 6 .

FIG. 8 is a top plan view of the injector docking device of FIG. 6 .

FIG. 9 is a bottom plan view of the injector docking device of FIG. 6 .

FIG. 10 is a side, cross-sectional view of the injector docking deviceof FIG. 6 taken along lines 10-10 of FIG. 6 .

FIGS. 11-20 illustrate a procedure for implanting an intraocular shuntinto an eye using an injector and the injector docking device of FIG. 6, according to some embodiments.

FIG. 21 illustrates another procedure for implanting an intraocularshunt into an eye using only an injector, according to some embodiments.

FIG. 22 illustrates a cross-section of the injector shown in FIG. 21 ,according to some embodiments.

FIGS. 23 and 24 illustrate portions of an injector docking device foruse with an injector, according to some embodiments.

FIGS. 25 and 26 illustrate another procedure for implanting anintraocular shunt into an eye using an injector and the injector dockingdevice shown in FIGS. 23 and 24 , according to some embodiments.

FIGS. 27-31F illustrate another injector docking device formed unitarilywith an injector, as well as a related procedure for implanting anintraocular shunt into an eye, according to some embodiments.

FIGS. 32-35D illustrate yet another injector docking device formedunitarily with an injector, as well as a related procedure forimplanting an intraocular shunt into an eye, according to someembodiments.

FIGS. 36A-38C illustrate additional procedures and outflow regionlocations for implanting an intraocular shunt into an eye using aninjector and the injector docking device of FIG. 6 , according to someembodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. Itshould be understood that the subject technology may be practicedwithout some of these specific details. In other instances, well-knownstructures and techniques have not been shown in detail so as not toobscure the subject technology.

Further, while the present description sets forth specific details ofvarious embodiments, it will be appreciated that the description isillustrative only and should not be construed in any way as limiting.Additionally, it is contemplated that although particular embodimentsmay be disclosed or shown in the context of ab externo procedures, suchembodiments can be used in ab interno procedures. For example, althoughvarious ab externo approaches are discussed herein, any embodiment ofthe injector docking devices and methods described herein can bemodified to provide an ab interno procedure (i.e. entering through thecornea, across the anterior chamber toward a target location) such thatan outflow region of the shunt is positioned with the location of ableb. Furthermore, various applications of such embodiments andmodifications thereto, which may occur to those who are skilled in theart, are also encompassed by the general concepts described herein.

The present application discloses ab externo approaches and devices forpositioning an intraocular shunt with one end (fluid entry end) placedinto the anterior chamber and the other end (outflow end) placedpreferably into a target outflow region, such as the subconjunctivalspace, without creating a conjunctival cutdown (dissection). Otherpossible shunt outflow locations or target outflow regions include thesub-Tenon's space (between Tenon's and sclera), the intra-Tenon's space(between layers of Tenon's capsule, or in the intra-Tenon's adhesionspace), the over-Tenon's space (between Tenon's and conjunctiva), thesuprachoroidal space, the intrascleral space, Schlemm's canal, thevitreous space, the episcleral vein, the supraciliary space, or thesuprascleral space.

In some embodiments of the methods and devices disclosed herein, theinjector can be configured to allow an intraocular shunt, such as a gelshunt (e.g., supported by a needle or shaft of the injector) to bepositioned or oriented at a desired angle (“entrance angle”) relative toa surface of the eye prior to implantation in order to allow the shuntoutflow end to be positioned in a desired target outflow region, such asthe suprachoroidal or vitreous space. For example, the injector can bemanually positionable relative to the surface of the eye to allow thesurgeon to adjust the entrance angle to any of a variety of anglesbefore injecting the shunt into the eye.

Further, an injector docking device can also be used in combination withthe injector to provide a fixed entrance angle, and a surgeon can selecta specific injector docking device from a variety of rings havingdifferent fixed entrance angles based on a desired entrance angle. Insome embodiments, the injector docking device can be removably couplableto the eye (e.g., via a vacuum force) or provide a smooth surface thatcan be positioned or abutted against the eye without being securedrelative thereto. For example, some embodiments disclosed herein providean associated injector docking device for maintaining, securing, orfixing a position of an injector relative to the eye during eye surgery.

Additionally, according to some embodiments, a shunt or stent can beinjected into any of the nasal quadrants of the eye using an ab externoprocedure. For example, the shunt can be injected in the nasal superior,nasal inferior, temporal superior, or temporal inferior quadrants.

Advantageously, using some embodiments of this procedure, a shunt can bemore easily placed in every quadrant of the eye because the injectorneedle no longer has to traverse the entire anterior chamber (comparedto ab interno approaches). Thus, ab externo procedures are disclosedherein that enable a surgeon to quickly and accurately place anintraocular shunt into any quadrant of the eye and position an outflowend of the shunt into one of a variety of outflow regions withoutcreating a scleral flap or conjunctival dissection.

Anatomy of the Eye

FIG. 1 provides a schematic diagram of the general anatomy of the eye.An anterior aspect of the anterior chamber 1 of the eye is the cornea 2,and a posterior aspect of the anterior chamber 1 of the eye is the iris4. Beneath the iris 4 is the lens 5. The anterior chamber 1 is filledwith aqueous humor 3. The aqueous humor 3 drains into a space(s) 6 deepto the conjunctiva 7 through the trabecular meshwork (not shown indetail) of the sclera 8. The aqueous humor is drained from the space(s)6 deep to the conjunctiva 7 through a venous drainage system (notshown).

FIG. 2 is an enlarged view of the schematic diagram of FIG. 1 takenalong section lines 2-2. FIG. 2 illustrates a detail view of the sclera8 and surrounding tissue. As shown, the conjunctiva 7 attaches to thesclera 8 at the limbus 9.

Deep to the conjunctiva 7 is Tenon's capsule 10. Tenon's capsule 10comprises two layers (i.e., superficial and deep layers) and anintra-Tenon's adhesion space 11 that extends between the superficial anddeep layers of Tenon's capsule 10. The intra-Tenon's adhesion space 11surrounds the eye circumferentially. The intra-Tenon's adhesion space 11can extend around the eye posterior to the limbus 9.

In the view of FIG. 2 , deep to the intra-Tenon's adhesion space 11 is arectus muscle 20. The eye has four rectus muscles (superior, inferior,lateral, and medial) that attach to sclera via a rectus tendon. FIG. 2illustrates that the rectus muscle 20 attaches to the sclera 8 via arectus tendon 22. For illustration purposes, the rectus tendon 22 isshown inserting onto the sclera 8. In some cases, there may not be aclear insertion point of the rectus tendon 22 onto the sclera 8, butthere will be a gradual transition between the rectus tendon 22 and theintra-Tenon's adhesion space 11.

Additionally, as illustrated in FIG. 1 , Tenon's capsule 10 and theintra-Tenon's adhesion space 11 is illustrated extending anteriorlyrelative to and superficial to the rectus muscle 20. As also shown,posterior to the rectus tendon, Tenon's capsule 10 and the intra-Tenon'sadhesion space 11 also extend deep to and around the rectus muscle 20.In this region, there is a reflection of Tenon's capsule 10 and theintra-Tenon's adhesion space 11 from the rectus muscle 20 onto the globeor sclera 8. Thus, Tenon's capsule 10 and the intra-Tenon's adhesionspace 11 envelop or encapsulate the rectus muscle 20.

FIG. 2 illustrates that in some locations, Tenon's capsule 10, and thus,the intra-Tenon's adhesion space 11, surrounds a rectus muscle 20.According to some embodiments of the methods disclosed herein, theintra-Tenon's adhesion space 11 can be accessed from the anteriorchamber 1. Tenon's capsule 10 and the intra-Tenon's adhesion space 11surround the eye circumferentially.

FIG. 2 also illustrates the drainage channels of the eye, includingSchlemm's canal 30 and the trabecular meshwork 32, which extend throughthe sclera 8. Further, deep to the sclera 8, the ciliary body 34 is alsoshown. The ciliary body 34 transitions posteriorly to the choroid 40.Deep to the limbus 9 is a scleral spur 36. The scleral spur 36 extendscircumferentially within the anterior chamber 1 of the eye. Further, thescleral spur 36 is disposed anteriorly to the anterior chamber angle 38.Furthermore, “anterior chamber angle tissue” can refer to the eye tissuein the region extending along and/or including one or more of the cornea2, the sclera 8, Schlemm's canal 30, the trabecular meshwork 32, theciliary body 34, the iris 35, or the scleral spur 36.

Accordingly, for definitional purposes, the space between theconjunctiva 7 and Tenon's capsule 10 or the intra-Tenon's adhesion space11 is referred to herein as subconjunctival space 60 (here shown as apotential space). The space between the sclera 8 and Tenon's capsule 10or the intra-Tenon's adhesion space 11 is referred to herein assuprascleral space 61 (here shown as a potential space). Further, thespace between a deep layer or surface 62 and a superficial layer orsurface 64 of Tenon's capsule 10 is referred to herein as theintra-Tenon's adhesion space 11. Additionally, the space within thesclera 8 (i.e., between the superficial and deep layers or surfaces ofthe sclera 8) is referred to herein as intrascleral space 66 (here shownas a potential space). The space between the sclera 8 and the ciliarybody 34 is referred to herein as supraciliary space 68 (here shown as apotential space). Finally, the space between the sclera 8 and thechoroid 40 is referred to as suprachoroidal space 70 (here shown as apotential space). The supraciliary space 68 can be continuous with thesuprachoroidal space 70.

Injectors

In accordance with some embodiments, a variety of injectors or systemsknown in the art may be used to perform the methods disclosed herein. Incertain embodiments, deployment into the eye of an intraocular shunt canbe achieved using a hollow needle or shaft configured to hold the shunt,as described herein. The needle can be coupled to an injector or be apart of the injector itself. Some of the methods disclosed herein enablea surgeon to use an injector in a “freehand” procedure (i.e., withoutusing docking, securement, or coupling devices) to inject a shunt intothe eye. However, some of the methods disclosed herein also enable asurgeon to use a “guiding” injector docking device. Optionally, theinjector docking device can be temporarily affixed or secured to the eyeor to the inserter itself during the procedure. Such injector dockingdevices can be retrofitted to existing injectors or incorporated intoinjector designs.

Some injectors that are suitable for placing shunts according to someembodiments include, but are not limited to, injectors described in U.S.Pat. Nos. 6,007,511, 6,544,249, U.S. Patent Publication No.2008/0108933, U.S. Pat. No. 8,663,303, U.S. patent application Ser. No.12/946,222, filed on Nov. 15, 2010, U.S. patent application Ser. No.12/946,645, filed on Nov. 15, 2010, U.S. patent application Ser. No.14/541,070, filed on Nov. 13, 2014, and U.S. Patent Application No.62/170,338, filed on Jun. 3, 2015, the entire contents of each of whichis incorporated by reference herein.

In some embodiments, an injector can be provided in which the injectordocking device and the injector are formed unitarily, coupled with eachother, or otherwise formed from a single, continuous housing or materialto form a single handheld unit. Otherwise, the injector docking devicecan be removably coupled to the injector. For example, the injectordocking device can be prepared for use with an injector, and in someembodiments as a retrofit to an existing injector.

Furthermore, in accordance with some embodiments, the injectorsdisclosed herein can use one, two, or more actuation mechanisms,including buttons, sliders, rotational components, and combinationsthereof. For example, an injector can be configured to include twobuttons, a button and a slider, two sliders, and/or rotationalcomponents. The advancement or withdrawal of a component of the injector(such as a plunger rod, needle, sleeve, or other component) can be doneeither through actuation of a button and/or a slider, and may be manualor use an energy stored mechanism (e.g., spring loaded actuation,electrical motor, or magnetic movement).

“Guided” Injector Docking Devices

As discussed above, some embodiments disclosed herein provide aninjector docking device for maintaining, securing, or fixing a positionof an injector relative to the eye during eye surgery. The injectordocking device can guide or otherwise facilitate insertion of the needleinto the eye when performing some embodiments of the proceduresdisclosed herein. The injector docking device can serve as a securementor coupling device to facilitate precise alignment or otherwise provideguided support or assistance to a deployment device or injector inplacement of a shunt. For example, the injector docking device cancomprise a needle or injector guidance port or bore. The injectorguidance port can provide a location for the injector to be inserted inorder to achieve guided precision. In some embodiments, when theinjector docking device is coupled to or removably affixed to the eye,the injector guidance port can control the angle at which the needleenters the eye, the depth to which the needle penetrates, and the finallocation of the shunt after implantation.

Thus a “guided” delivery can be performed by creating a generally fixedspatial or geometrical relationship between the eye and the injector(and in some embodiments, having the docking device coupled to orremovably affixed to the eye). This can advantageously allow the surgeonto establish a predetermined entry point for the needle on the surfaceof the eye, verify targeting and a pre-planned position of the shunt,and benefit from the support and guidance that the injector dockingdevice provides to the injector as the injector is inserted into orengaged with the injector docking device. The surgeon can perform thisguided procedure to advance the needle along a precise trajectory withinthe eye and ensure accurate placement of the shunt within the eye. Asnoted, in some embodiments of a guided procedure, the injector dockingdevice is coupled to or removably affixed to the eye, using suction,frictional engagement, and/or other mechanical engagement.

FIGS. 3A-18 and 21-38C illustrate various embodiments of injectordocking devices and uses thereof. In accordance with some embodiments,the injector docking device can comprise a needle support component andat least one eye-contacting surface. The needle support component canhave proximal and distal portions and a longitudinal needle axisextending between the proximal and distal portions. The supportcomponent can be configured such that, when coupled to an intraocularshunt inserter, the proximal or distal portion supports the inserter toalign a needle of the inserter with the longitudinal needle axis.Further, the eye-contacting surface can be disposed on the distalportion of the needle support component. The eye-contacting surface canbe positionable against the eye to permit a clinician to align thedevice relative to an indicium or indicia of the eye thereby aligningthe needle relative to the eye.

For example, FIGS. 3A-5 illustrate an embodiment of an injector dockingdevice 72 having a body 73 and a needle support component 74 thatextends from a proximal portion of the body 73 toward a distal portionthereof. A distal portion of the injector docking device 72 can compriseone or more eye-contacting surfaces 76 to facilitate alignment of theneedle 92 or injector 90 relative to an eye 86. In some embodiments, thebody 73 of the docking device 72 can flare outwardly from the proximalportion or needle support component 74, such that the eye-contactingsurfaces 76 have a greater cross-sectional profile than the needlesupport component 74 of the device 72. However, in some embodiments, thebody of the device can have a substantially constant cross-sectionalprofile, such as circular, polygonal, square, rectangular, or othernon-tapering profiles. An embodiment of a device 77 having a body with asubstantially constant cross-sectional profile is shown in FIG. 3B.Other than the tapering body, the features of the device 77 can besimilar to those of device 72 and will not be repeated herein forbrevity.

As shown in FIG. 3A, the needle support component 74 can accommodate,mate with, or otherwise engage or support a needle 92 and/or a portionof an injector 90. The needle support component 74 can comprise a port78, such as an elongate aperture, lumen, or bore that defines a needleaxis 94 extending from the proximal portion toward the distal portion ofthe injector docking device 72. A needle 92, sleeve 91, and/or otherportion of an injector 90 can be fitted into the shaft 78 from theproximal portion. In some embodiments, an inner profile of the needlesupport component 74 can closely match an outer profile of the needle92, sleeve 91, or other portion of the injector 90.

The eye-contacting surface 76 can be configured for engagement againstan external surface of the eye 93. FIGS. 3A-5 illustrate theeye-contacting surface 76 can comprise at least one surface configuredto mate against the eye. For example, the surface can comprise a concaveor arcuate surface that approximates the external surface of the eye inorder to position the injector docking device 72 against the eye 93. Theeye-contacting surface can be configured to facilitate alignment of theinjector docking device 72 with one or more indicia of the eye 93, suchas the cornea, the corneal limbus, and the pupil.

In some embodiments, the eye-contacting surface 76 can comprise ahorizontal radius 80 and a vertical radius 82. In accordance with someembodiments, when the eye-contacting surface 76 is engaged against theexternal surface of the eye 93, the horizontal radius 80 can be orientedtransverse relative to the visual axis 95 of the eye 93, and thevertical radius 82 can be oriented normal relative to the visual axis 95of the eye 93.

In some embodiments, the horizontal radius 80 can define a curved upperedge 84 of the injector docking device 72 that can be aligned with thecorneal limbus 96 to facilitate alignment of the injector docking device72 relative to the visual axis 95 of the eye 93. In some embodiments,the vertical radius 82 can facilitate alignment of the injector dockingdevice 72 so that the needle axis 94 intersects the target outflowregion and the anterior chamber angle of the eye 93. In someembodiments, the vertical radius 82 can comprise an angle of betweenabout 10 and 60 degrees, between about 20 and 50 degrees, between about25 and 45 degrees, between about 30 and 40 degrees, or about 35 degreesfrom horizontal.

Referring to FIG. 4 , a needle 92, sleeve 91, or other portion of theinjector 90 is permitted to extend through the needle support component74 from the proximal portion toward the distal portion of the injectordocking device 72. In this pre-injection configuration, the needle 92does not extend beyond the distal portion of the injector docking device72. However, referring to FIG. 5 , with the eye-contacting surface 76engaged against an external surface of the eye 93, the needle 92 can beadvanced toward an injection configuration. In moving toward theinjection configuration, the needle 92 can be advanced toward the eye 93such that the needle 92 extends beyond the distal portion of theinjector docking device 72 and into the eye 93. Thereafter, a shunt canbe released into the eye using any of the procedures for releasing ashunt from any of the inserters disclosed or referred to herein.

In some embodiments, the injector docking device 72 can comprise alongitudinal restriction to restrict a needle 92 from travelling furtherthan a specified distance beyond the distal portion of the injectordocking device 72. The specified distance that the needle 92 ispermitted to extend beyond the distal portion can be configured tocorrespond to the maximum distance the implant or shunt carried withinthe needle 92 is to be placed in the eye 93.

For example, in the injection configuration, the needle 92 can extend apreset distance beyond the injection site so that an inflow end of theshunt can be positioned in the anterior chamber while an outflow end ofthe shunt is positioned within, adjacent to, or ready to be repositionedwithin a desired outflow region. In some embodiments, the longitudinalrestriction can comprise a shoulder that contacts a portion of theneedle 92, sleeve 91, or other portion of the injector 90 duringmovement of the needle toward the injection configuration. For example,the injector docking device 72 can comprise a shoulder positioned withinthe lumen of the needle support component 74. Thus, the needle 92,sleeve 91, or other portion of the injector 90 moving through the needlesupport component 74 can be stopped by a shoulder so that the needle 92advances only to the specified or preset distance beyond the distalportion.

In some embodiments, all or at least a portion of the injector dockingdevice 72 can be transparent. For example, a distal portion of theinjector docking device 72 can be transparent to facilitate visualalignment with an indicium of the eye, monitoring the position of theneedle 92, sleeve 91, or other portion of the injector 90, or tootherwise facilitate alignment of the injector docking device 72 withthe eye 93. In some embodiments, the distal portion can comprise alonger cross-sectional width than a proximal portion of the injectordocking device 72. In some embodiments, the distal portion comprises atapering cross-sectional width.

FIGS. 6-10 illustrate an embodiment of an injector docking device 100.The injector docking device 100 can comprise a body 102 and a needlesupport component 104 extending from the body 102. The needle supportcomponent 104 can accommodate, mate with, or otherwise engage andsupport a needle or a portion of an injector to facilitate alignment ofthe needle or injector relative to the eye.

For example, the needle support component 104 can comprise an elongateaperture or lumen into which a needle, sleeve, or other portion of aninjector can be fitted. In some embodiments, an inner profile of theneedle support component 104 can closely match an outer profile of theneedle, sleeve, or other portion of the injector.

The body 102 can comprise an eye-contacting portion that permits thebody 102 to be positioned against an external surface of the eye. Theeye-contacting portion of the body 102 can comprise one or more prongs,pads, semi-circular structures, circular structures, annular structures,semi-annular structures, semi-spherical structures, or sphericalstructures, and can have concave and/or convex shapes for mating againstone or more portions of the eye. In some embodiments, the body 102 cancomprise a scleral portion 106 and a corneal portion 108.

Further, as shown in FIG. 7 , the body 102 can comprise aneye-contacting portion 110 formed on a first side 112 of the body 102.The eye-contacting portion 110 can extend about a central axis 120 ofthe body 102. Further, the needle support component 104 can comprise aneedle or injector guidance port or bore 122 into which a needle of adelivery device can be passed.

In accordance with some embodiments, the central axis 120 can beintended to align with a straight ahead line of sight of the eye (i.e.,a central axis of the eye passing through a center of the cornea). Theinjector guidance port 122 can define a needle axis 124 extendingtransversely relative to the eye-contacting portion 110. In someembodiments, the needle axis 124 extends transversely relative to thecentral axis 120. For example, the needle axis 124 can extend relativeto the central axis 120 at an angle of between about 45 degrees andabout 90 degrees, between about 60 degrees and about 80 degrees, betweenabout 65 degrees and about 75 degrees, or about 70 degrees.

The relative angle between the central axis 120 and the needle axis 124can be determined based on the desired outflow region that is beingtargeted by the injector docking device. Generally, a more anterior orsuperficial target outflow region can have a higher relative anglecompared to a more posterior or deep target outflow region. For example,when targeting an outflow region at about where the rectus tendon 22inserts onto the sclera 8, the relative angle between the central axis120 and the needle axis 124 can be higher than when targeting an outflowregion posterior to or deep to this location (e.g., when targeting anoutflow region, such as the suprachoroidal space). The relative anglebetween the central axis 120 and the needle axis 124 can also beselected based on the desired target outflow region and the required“entrance angle” (i.e., the relative angle between the needle axis 124and a surface of the eye).

The injector docking device 100 can include a targeting ring oralignment aperture 128 to facilitate positioning of the injector dockingdevice 100 onto the eye. The targeting ring 128 can comprise a throughhole extending from an upper surface of the injector docking device 100there through to the eye-contacting portion 110. The targeting ring 128can allow a surgeon to look therethrough to see the eye and visuallyconfirm the position of the injector docking device 100 relative to theeye. For example, the targeting ring 128 can be used to see the corneaand roughly center the injector docking device 100 on the cornea. Thetargeting ring 128 can be configured to permit the surgeon to see any ofthe indicia of the eye, such as the cornea, the corneal limbus, and thepupil, to name a few.

FIGS. 6-10 illustrate that the body 102 can have a spherical innercontour along the eye-contacting portion 110 thereof. The eye-contactingportion 110 can extend fully or partially about the central axis 120. Asshown in FIGS. 6-10 , the eye-contacting portion 110 extends fully aboutthe central axis 120.

The eye-contacting portion 110 can comprise one or more regionsconfigured to contact specific physiological structures of the eye. Forexample, the eye-contacting portion 110 can comprise an outer section130 and an inner section 132. The outer section 130 can be configured tooverlie sclera of the eye while the inner section 132 can be configuredto overlie or abut the corneal limbus and/or the cornea of the eye.

The inner section 132 of the injector docking device 100 can beconfigured to contact the eye adjacent to the corneal limbus in order toengage the eye, create a seal against the eye, or otherwise facilitatesecurement of the eye-contacting portion 110 to the eye. For example,the inner section 132 can be positioned posterior to, anterior to, oragainst the corneal limbus. In some embodiments, the inner section 132of the injector docking device 100 can have an outer diameter 140 ofbetween about 9 mm and about 20 mm, between about 11 mm and about 18 mm,between about 13 mm and about 16 mm, or about 15 mm. Further, the innersection 132 can have an inner diameter 142 of between about 9 mm andabout 14 mm, between about 10 mm and about 13 mm, between about 10.5 mmand about 12 mm, or about 11 mm, 11.5 mm, 12 mm, or 12.5 mm.

As shown in FIG. 10 , the eye-contacting portion 110 of the injectordocking device 100 can have two different radii of curvature that canallow the ring to mate to the sclera and to mate to the cornea. Thisdouble-radius docking allows for self-centering of the docking device100 during the application of suction. Any slight misalignment duringthe suction application may otherwise cause the device 100 to shift suchthat the two different suction radius sections create an optimalsymmetrical shift. Alternatively or additionally, the cross hair andring feature 128 in FIG. 9 can permit independent center verification oralignment by centering its features visually to the patient's pupil. Forexample, the outer section 130 can have a radius of curvature 144 ofbetween about 11 mm and about 14 mm, between about 11.6 mm and about13.4 mm, between about 11.9 mm and about 12.9 mm, or about 12.4 mm. Insome embodiments, the radius of curvature 144 can approximate the radiusof curvature of the sclera of the eye in order to better mate againstthe sclera. The radius of curvature 144 can fall within acceptableranges of the radius of curvature of the sclera, as known in the art ormeasured using known methods. See, for example, Measurement of AnteriorScleral Curvature Using Anterior Segment OCT, Choi et al., Optom VisSci. 2014 July; 91(7):793-802. doi: 10.1097/OPX.0000000000000298, theentirety of which is incorporated herein by reference.

Further, the inner section 132 can have a radius of curvature 146 ofbetween about 6 mm and about 10 mm, between about 7 mm and about 9 mm,between about 7.6 mm and about 8.2 mm, or about 7.8 mm. The radius ofcurvature 142 can fall within acceptable ranges of the radius ofcurvature of the cornea, as known in the art or measured using knownmethods. See, for example, Curvature Analyses of the Corneal Front andBack Surface, Vojnikovic et al., Coll. Antropol. 37 (2013) Suppl.1:93-96, the entirety of which is incorporated herein by reference.

In some embodiments, the radii of curvature 144, 146 can also vary froma posterior region and anterior region thereof. For example, the radiiof curvature 144, 146 can increase in an anterior direction. Suchvariability can advantageously allow the outer section 130 and the innersection 132 to better mate against the sclera and cornea, respectively.

In addition, the intersection of the radii of curvature 144, 146 canform a ridge 148 that can mate against the corneal limbus of the eye.Further, the ridge 148 can advantageously further encourage theconcentricity or alignment of the injector docking device 100 to thecornea.

However, some embodiments can be created in which the inner and outersections 130, 132 have a common radius of curvature and a ridge isprovided at an intersection of the inner and outer sections 130, 132. Insuch embodiments, the ridge can extend inwardly toward a central axis ofthe device and have a height of less than about 1 mm, about 1 mm, about2 mm, or about 3 mm. The ridge can extend at least partially or entirelyaround a circular path at the intersection of the inner and outersections 130, 132.

The injector docking device 100 can use suction and/or one or morefrictional components, such as spikes or other engagement features tocouple the injector docking device to the eye. In some embodiments, theinjector docking device 100 can comprise a vacuum or suction featurethat allows the injector docking device 100 to engage the eye. Forexample, the injector docking device 100 can comprise a vacuum port orbore that is in fluid communication with at least one vacuum pocket orchannel to aid in engagement between the eye and the injector dockingdevice 100. The vacuum port can be used to provide vacuum pressure tothe injector docking device using a simple syringe, a gravity tube, orelectric pump.

For example, the injector docking device 100 can comprise a scleralvacuum pocket or channel and/or a corneal vacuum pocket or channel. Insome embodiments, the vacuum port can be coupled to both the scleralvacuum pocket and the corneal vacuum pocket such that a vacuum pressurecan be applied via the vacuum port to both pockets simultaneously.However, the vacuum port can also be coupled to only the scleral vacuumpocket or only the corneal vacuum pocket (e.g., if only one type ofpocket is present). In some embodiments, the scleral vacuum pocket andthe corneal vacuum pocket can have independent vacuum ports forindependently applying vacuum pressure or applying different magnitudesof vacuum pressure.

FIGS. 6-10 illustrate that the injector docking device 100 can comprisea scleral vacuum pocket or channel 160. The scleral vacuum pocket 160can extend at least partially along the eye-contacting portion 110 ofthe injector docking device 100. For example, in some embodiments, thescleral vacuum pocket 160 can be formed along the outer portion 130 ofthe injector docking device 100. Further, the depth and width of thescleral vacuum pocket 160 can define the maximum deformation of thesclera when a vacuum pressure is applied. In some embodiments, thescleral vacuum pocket 160 can have a depth of between about 0.2 mm andabout 1 mm, between about 0.3 mm and about 0.7 mm, or about 0.5 mm.Further, in some embodiments, the scleral vacuum pocket 160 can have awidth of between about 2 mm and about 5 mm, between about 3 mm and about4 mm, or about 3.5 mm.

In some embodiments, the injector docking device 100 can comprise asecondary corneal vacuum pocket or channel that extends along a cornealportion 108 of the injector docking device 100. The corneal vacuumpocket (not shown) can aid in suction and can be used in combinationwith the scleral vacuum pocket 160 or alone, instead of the vacuumpocket 160. Similarly to the scleral vacuum pocket 160, the depth andwidth of the corneal vacuum pocket can define the maximum deformation ofthe cornea when a vacuum pressure is applied. In some embodiments, thecorneal vacuum pocket can have a depth of between about 0.2 mm and about1 mm, between about 0.3 mm and about 0.7 mm, or about 0.5 mm. Further,in some embodiments, the cornea vacuum pocket can have a diameter ofbetween about 10 mm and about 12 mm, between about 10.5 mm and about11.75 mm, or about 11.5 mm.

Additionally, in some embodiments that include both the scleral vacuumpocket 160 and a corneal vacuum pocket, the corneal vacuum pocket may befluidly interconnected to the vacuum source or vacuum port 150 of thescleral vacuum pocket 160. However, a separate vacuum source or vacuumport can also be used. Further, when the injector docking device 100comprises only a corneal vacuum pocket, a vacuum port can be fluidlyinterconnected with the corneal vacuum pocket and be positioned in acentral location along an outer surface of the body 102 of the injectordocking device 100.

In accordance with some embodiments, injector docking device 100 cantherefore provide suction on and/or otherwise engage the cornea and/orbelow corneal limbus (e.g., along the sclera). As noted, an alternativeto suction is to provide a frictional or grippy surface, such as ridges,hooks, or spikes that may penetrate or otherwise engage the conjunctiva.Such a surface can enable the surgeon to contact the injector dockingdevice against the eye and achieve suitable frictional and/or mechanicalengagement with the eye. However, suction and mechanical engagement canboth be used in some embodiments.

In use, the targeting ring 128 can be used to center the injectordocking device 100 on the cornea before applying suction and/ormechanically engaging the injector docking device 100 with the eye.Thereafter, suction can be applied with a simple syringe, a gravitytube, or electric pump. The vacuum pressure applied to the eye can bestrong enough to couple the injector docking device 100 to the eye inorder to allow a surgeon to move the eye using the injector dockingdevice 100. Further, in some embodiments, the vacuum pressure can beadjustable. For example, suction can be adjusted by adjusting thenegative pressure and/or the surface area covered by vacuum pocket(s).Suction pressure and surface area are accounted for in the formula:P=F/A, F=P*A. As such, increasing the surface area can directly increasethe suction force.

As noted above, the injector docking device 110 can serve as a precisealignment guide for placement of the deployment device or injector.Accordingly, the injector docking device can comprise a needle support104 having the injector guidance port 122. The injector guidance port122 provides a location for the injector to be inserted with guidedprecision. The injector guidance port 122 can control the angle theneedle enters the eye based on the angle of the needle axis 124 relativeto the central axis 120. Further, the injector guidance port 122 canhave a depth or length that limits the depth to which the needle orshaft of the injector penetrates, as well as the final location of theshunt after implantation. The dimensions of the injector guidance port122 can be based at least in part on the actuation or movement of theinjector in advancing and releasing the shunt. For example, the injectorguidance port 122 can comprise a shoulder 168 against which a distal endof a sleeve or component of the injector can be abutted in order tolimit distal advancement of the injector relative to the injectorguidance port 122. As such, advancement or travel of the needle andshunt can be defined by the actuation of the injector (including themovement of the needle and/or plunger of the injector).

In some embodiments, the injector guidance port 122 of the injectordocking device 100 be longer and much larger in diameter than a needlebore 172 thereof (e.g., a diameter of the injector guidance port 122 canbe about 5, about 6, about 7, about 8, about 9, about 10, about 11, orabout 12 times as large as a diameter of the needle bore 172). Further,the diameter of the needle bore 172 can be much larger in diameter thana needle of the injector (e.g., twice as large) in order to ensure thatwhen inserting the needle into the needle bore 172, the needle does notcontact the sidewall of the injector guidance port 122 or the needleport 172 (which can damage or dull the needle).

In accordance with some embodiments, the injector docking device 100 canalso comprise a bleb or ballooning pocket 170. For example, inaccordance with some embodiments of the methods disclosed herein, when ableb is created to facilitate placement of an outflow end of the shuntwithin a target outflow region defined at least in part by the bleb, thebleb pocket 170 can be positioned over the bleb. The bleb pocket 170 canbe configured to limit the expansion of the bleb to an optimal shapebefore the needle enters the conjunctiva. Further, the bleb pocket 170can enable excess ballooning of the bleb to be pushed below or outsidethe injector docking device 100. However, as discussed further herein,some embodiments of the procedure can be performed without creating ableb or otherwise ballooning the target outflow region prior toinjecting the shunt into the eye. Accordingly, some embodiments of theinjector docking devices disclosed herein can be formed without a blebpocket 170 incorporated into the body 102 of the injector docking device100.

Advantageously, the injector docking device 100 can potentially beoriented in all four quadrants of the eye (nasal superior, nasalinferior, temporal superior, or temporal inferior). The surgeon cantherefore avoid problem areas of a patient's eye, such as locations ofpreviously failed surgeries (e.g., where there may exist scarred-downtissue or failed Trabeculectomy areas). Further, the surgeon canadvantageously assess which quadrants are available by rotating thepatient's eye and assess access to the injector guidance port dependingon anatomical features of the patient.

“Guided” Ab Externo Implantation Methods

As discussed herein, new methods for ab externo implantation of a shuntcan provide a simple and safe procedure that can be performed in anoffice setting. These new ab externo approaches can use an injectordocking device and can enable an outflow end of a shunt to be deployedunder/into any of a variety of outflow regions without making a scleralflap or otherwise requiring a conjunctival dissection. A surgeon caninject a fluid ab externo into the target outflow region to create ableb—before and/or after implantation of the shunt—in order tofacilitate positioning of an outflow end of a shunt within the targetoutflow region. The outflow end of the shunt can be positioned in thesubconjunctival space or over-Tenon's space (between Tenon's andconjunctiva), the suprascleral or sub-Tenon's space (between Tenon's andsclera), the intra-Tenon's space (between layers of Tenon's capsule, orin the intra-Tenon's adhesion space), the choroidal and suprachoroidalspace, the intrascleral space (between layers of sclera), Schlemm'scanal, the vitreous space, the episcleral vein, or the supraciliaryspace.

Some embodiments of the methods and devices disclosed herein allow asurgeon to use an injector docking device to perform a “guided”procedure in which the injector docking device creates a generally fixedspatial or geometrical relationship between the eye and the injector.This fixed relationship allows the surgeon to use the injector dockingdevice to establish or assist in defining a predetermined entry pointfor the needle on the surface of the eye and benefit from the supportand guidance that the injector docking device provides to the injectoras the injector is inserted into or engaged with the injector dockingdevice. The surgeon can perform this guided procedure to advance theneedle along a precise trajectory within the eye and ensure accurateplacement of the shunt within the eye.

FIGS. 11-20 illustrate the steps of a procedure for ab externoimplantation of a shunt, according to some embodiments. FIG. 11illustrates placement of an injector docking device 100 onto an eye of apatient 202. Further, an injector 204 is shown as being inserted into aninjector guidance port of the injector docking device 100. FIG. 11 showsthat the injector guidance port of the injector docking device 100 ispositioned in a superior nasal position. However, as noted above, theinjector docking device can be positioned such that the injectorguidance port is oriented in any of a variety of directions so that thesurgeon can insert the injector into a variety of different quadrants ofthe eye, including the superior temporal, inferior temporal, andinferior nasal. Further, depending on the placement or injector dockingdevice configuration, the surgeon can position the injector so that theneedle accesses the anterior chamber of the eye at a variety ofdifferent angles.

FIG. 12 illustrates an initial placement step of the injector dockingdevice 100 onto an eye 210. Prior to placement of the injector dockingdevice 100 onto the eye 210, a bleb 212 can be formed. The bleb 212 canbe formed by an injection prior to the placement of the injector dockingdevice 100. The injection can comprise a BSS, a viscoelastic, ananti-metabolite, a drug-eluting solution, water, and/or a combinationthereof. After the bleb 212 is formed, the injector docking device 100can be positioned against the eye, with the bleb pocket 170 positionedover the bleb 212.

Accordance with some embodiments, the formation of the bleb orballooning of a target outflow region can be performed by positioning abevel of a small needle (e.g., 27 G or 30 G) within the target outflowregion space or potential space, and slowly injecting fluid into thespace. For example, by placing the bevel of the needle close to sclera,anterior to Tenon's layer and between conjunctiva and sclera, theconjunctiva can be ballooned away from the sclera. Also, for example, ifthe bevel of the needle is positioned within Tenon's capsule or withinintra-Tenon's adhesion space, fluid can be injected into and absorbed bythe Tenon's capsule. Various other spaces or potential spaces can beballooned to facilitate placement therein of an outflow end of a shunt,according to some embodiments, thus creating a desired target outflowregion.

Optionally, the injector docking device 100 can be moved to its finalposition using the targeting ring 128 to verify alignment withanatomical structures of the eye, such as the cornea or pupil. Further,in some embodiments, after the injector docking device 100 is in itsfinal position, suction can be applied using one or more of the scleralvacuum pocket or the corneal vacuum pocket. Thereafter, the injector canbe inserted and readied for actuation. In some embodiments, the injectorcan comprise a 27 G needle or other suitable size.

When placing the injector into the injector guidance port 122, theneedle of the injector can be in an exposed position or withdrawn into asleeve or housing of the injector so that the needle is not exposed. Forexample, as shown in FIG. 13 , an injector 220 can be inserted into theinjector guidance port 122 in a configuration in which a needle 222 ofthe injector 220 is exposed or extends distally beyond a sleeve 224 ofthe injector 220. In this manner, the needle 222 can already be out sosurgeon feels it directly when simultaneously advancing the injector 220further into the injector guidance port 122 and the needle 222 into thebleb 212.

Referring now to FIG. 14 , as the needle 222 is advanced, the needle 222may collapse conjunctiva to sclera before piercing. The shunt 230 andthe pusher rod 232 may travel forward with the needle 222. For example,as shown in FIG. 15 , the shunt 230 and the pusher rod 232 may travelforward with the needle 222 and penetrate conjunctiva 228 of the eye 210until reaching to a final position for the shunt 230, which is also astop position for the sleeve 224 abutting the shoulder 168 of theinjector guidance port 122.

In some instances, as the needle penetrates the eye and is advancedthrough the bleb into the target outflow region, the superficial layerof the target outflow region (e.g., the conjunctiva 228 or bleb 212) maybe pushed down, compressed, or deflated. For example, during advancementof the needle 222 into the bleb 212, the bleb 212 may be partially orfully pushed down or compressed (e.g., against the sclera) locally bythe needle 222. In the case that the superficial layer of the targetoutflow region is pushed down, compressed, or deflated, retraction ofthe needle 222 can pull back or cause the superficial layer of thetarget outflow region (e.g., the conjunctiva 228 or bleb 212) to reboundto its previously inflated size (e.g., as shown in FIG. 12 ), thusensuring that the proximal or outflow end of the shunt 230 is positioneddeep to the superficial layer of the target outflow region (e.g., theconjunctiva 228 or bleb 212).

In some embodiments, the “pull back” of the needle 222 or rebounding ofthe bleb 212 can be further facilitated by a “top-off” injection offluid into the bleb 212 or target outflow region after the needle 222has been fully inserted into the eye 210. For example, FIG. 15 alsoillustrates that after deflation of the bleb 212, a surgeon can addadditional fluid to reinflate the bleb 212. This additional fluid can beinjected using the needle 222 after the shunt is ejected from the needle222 or by using a separate needle.

Referring to FIGS. 15-17 , the shunt 230 can be advanced to orpositioned at a final target position within the eye 210. If the shunt230 is not already positioned at the distal end of the needle 222 (e.g.,during advancement of the needle 222 is illustrated in FIGS. 14 and 15), the shunt 230 can be advanced by the actuation of the pusher rod 232until reaching a position as illustrated in FIG. 15 .

Once the shunt 230 is in its final position, the needle 222 can bepartially retracted while position of shunt 230 is maintained by thepusher rod 232. Further, FIGS. 16 and 17 illustrate that the proximalwithdrawal of the needle 222 can serve to pull the superficial layer ofthe target outflow region (e.g., the conjunctiva 228) superficial to anoutflow end 240 of the shunt 230. Proximal withdrawal of the needle 222can therefore pull back the superficial layer of the target outflowregion due to friction, but if friction not enough, additional fluid canbe injected, as discussed above.

After the needle 222 has been fully withdrawn (as shown in FIG. 17 ),the pusher rod 232 and injector 220 can be retracted and removed, asshown in FIG. 18 . After the pusher rod 232 fully retracted from thebleb 212, the injector docking device 100 can be removed, as shown inFIG. 19 .

In accordance with some embodiments of the procedure, after the injectordocking device is removed, the bleb can optionally be compressed orpushed down by the surgeon (e.g., using a sponge, q-tip, vexel, orfinger) to gently urge the outflow end of the shunt toward a deep layerof the target outflow region. For example, as shown in FIG. 20 , thebleb 212 can be pushed down from the limbus towards the superior part ofthe bleb 212 to gently urge the outflow end 240 of the shunt 230 towarda deep layer of the target outflow region. As shown, the outflow end 240of the shunt 230 can be laid down flat onto or against the sclera.Compression of the bleb may not be necessary, especially if a BSS isused. Additionally, repositioning of the shunt may be done at thismoment, if desired. Furthermore, the bleb will continue to deflate andeventually reduce further in size from that illustrated in FIG. 20 . Thepuncture hole in the conjunctiva 228 can be closed with fibrin glue or asmall suture, if desired.

In accordance with some embodiments, if the shunt outflow end 240protrudes from the conjunctiva 228 at this stage in the procedure, thesurgeon can balloon the target outflow region by injecting additionalfluid into the bleb 212. This ballooning can cause the target outflowregion to envelop the outflow end 240 of the shunt 230. Similarly, insome embodiments, when no injector docking device is used, a surgeon caninject fluid into the target outflow region after the injector isremoved in order to cause the target outflow region to envelop theoutflow end of the shunt, as discussed below.

“Freehand” Ab Externo Implantation Methods and Devices

As noted above, various embodiments of the methods and devices disclosedherein allow a surgeon to use an injector docking device to perform a“guided” procedure in which an injector docking device creates agenerally fixed spatial or geometrical relationship that assists indefining an entry point for the needle on the surface of the eye. Thesurgeon can perform this guided procedure to ensure accurate placementof the shunt within the eye. Additionally however, some embodiments ofthe methods and devices disclosed herein can enable a surgeon to performa “freehand” procedure in which an injector docking device is not used.FIG. 21 illustrates an embodiment of a device and procedure in which“freehand” placement of a shunt is performed without an injector dockingdevice.

FIG. 21 shows an injector 300 being used to deliver a shunt into an eye302. The injector 300 can be any of a variety of injectors, includingprior art injectors. However, the methods disclosed herein, whether aprior art injector is used or not, can be advantageous and enable asurgeon to perform ab externo placement of a shunt without creating ascleral flap or otherwise requiring a conjunctival dissection, asdiscussed above.

Referring to FIG. 21 , the injector 300 can comprise a needle 310, ahousing 312, an actuator 314, and an actuation mechanism disposed withinthe housing 312 and responsive to the actuator 314 for releasing theshunt from the needle 310. As discussed above, a surgeon can approachthe eye 302 freehand (e.g., without the use of an injector dockingdevice engaged with the eye or otherwise providing a fixed support andpredetermined entry point into the eye for the needle of the injector).The surgeon can determine the proper entrance area and entrance anglefor the needle without the use of an injector docking device. Thesurgeon can inject the needle 310 through the conjunctiva and sclera(e.g., similar to the needle track they already do for the Ahmed orBaerveldt tube shunt placements).

Thereafter, the surgeon can compress the actuator 314 in order to causethe actuation mechanism to release the shunt. For example, the actuationmechanism can advance a plunger rod within the needle 310 to distallyadvance the shunt within the needle 310 and/or cause the needle 310 tobe retracted proximally relative to the shunt, thereby exposing theshunt. Features of injectors described in related U.S. PatentApplication Publication Nos. 2010/0100104, 2012/0123430, and2012/0123436 and International Patent Application No. PCT/US2014/065515can be incorporated into some embodiments of the devices and proceduresdisclosed herein, the entireties of the disclosures of each of which areincorporated herein by reference.

In addition, according to some embodiments of the procedures disclosedherein, FIG. 21 illustrates that the procedure can be performed withoutcreating a bleb or otherwise ballooning the target outflow region priorto implanting the shunt. Accordingly, without pre-implantation blebcreation or ballooning of the target outflow region, at the end ofeither a “freehand” procedure or a “guided” procedure (and after theinjector removal), the shunt outflow end would stick out of the eye.Thereafter, the surgeon can balloon the target outflow region up aroundthe shunt outflow end or “out” location until the conjunctiva and thetarget outflow region fully engulf the shunt outflow end, thuspositioning the shunt fully inside the bleb or balloon (and the shuntoutflow end is positioned within the target outflow region). At thatpoint, the bleb can be pushed down and thereby laying the shunt flatagainst the sclera, as described herein.

Accordingly, some embodiments of the ab externo methods disclosed hereincan be performed without any guidance or assistance from otherstructures and can rely solely on placement and injection of the needleby the surgeon. These “freehand” procedures may be performed in asurgical setting and can incorporate many of the features of the methodsdisclosed herein, such as pre- and/or post-implantation bleb creation orballooning of the target outflow region.

Additional “Guided” Ab Externo Implantation Methods and Devices

In accordance with some embodiments, any of the methods disclosed hereincan be implemented using a shunt that has one or more color features tofacilitate or confirm placement of the shunt within the eye. Forexample, in some embodiments, the shunt can comprise one or more ringsor indicia at one or more locations along the length of the shunt, suchas at discrete intervals, such as every for 2 mm. Further, the shunt canbe stained or comprise a color to provide visual contrast against thesclera, conjunctiva, and/or other aspects of the eye to facilitatevisualization of the shunt during the procedure. Additionally, inaccordance with some embodiments, whether the shunt comprises one ormore colored features, the method can be implemented using a gonio lensto verify placement or positioning of the shunt within the eye.

Optionally, in some embodiments, the injector 300 can comprise a sleeve316 or the housing 312 can be dimensioned provide a longitudinalplacement reference or stopper 318 that contacts the outside of the eye302 once a proper needle depth has been reached. The stopper 318 of thesleeve 316 can be a blunt distal end of the sleeve 316. For example,features of contact sleeves and injectors described in related U.S. Pat.No. 9,192,516 can be incorporated into some embodiments of the devicesand procedures disclosed herein, the entirety of the disclosure of whichis incorporated herein by reference. Such embodiments can therefore becharacterized as semi-guided in that the depth of needle penetration canbe limited by the sleeve.

FIG. 22 illustrates a cross-section of the injector 300 shown in FIG. 21, according to some embodiments. The injector 300 can comprise a pusherrod 330 disposed within a lumen of the needle 310. The pusher rod 330can abut a proximal end of a shunt 332 disposed within the needle 300.Further, the longitudinal position of the pusher rod 330 along a centralaxis 336 of the injector 300 can be fixed relative to the housing 312.Furthermore, the actuator 314 can comprise an actuator contact portion340. Upon depression of the actuator 314 into the housing 312, theactuator contact portion 340 can move downwardly until contacting aneedle retractor component 350. The needle retractor component can becoupled to the housing 312 at a proximal end 352 and to the needle 310at a distal end 354.

In use, the surgeon can depress the actuator contact portion 340 untilit contacts the needle retractor component 350, and continued depressionof the actuator 314 can cause the needle retractor component 350 todeflect away from the central axis 336 of the injector 300. Because theneedle retractor component 350 is coupled at its proximal end 352 to thehousing 312, the deflection will cause the distal end 354 of the needleretractor component 350 to be moved toward the proximal end 352, thuscausing the needle 310 to be proximally withdrawn into the housing 312.As this occurs, the pusher rod 330 can maintain its longitudinalposition along the central axis 336, thus causing the shunt 332 to beexposed and released as the needle 310 is proximally retracted relativeto the pusher rod 330 and the shunt 332.

In accordance with some embodiments, the sleeve 316 can cooperate with amodular injector docking device to provide guidance to the injector.FIG. 23 illustrates that the sleeve 316 can comprise a proximalengagement portion 380 that can be coupled to a distal end of a housingof an injector. In some embodiments, the sleeve 316 can be retrofittedonto existing injectors. Further, the sleeve 316 comprises an outersurface 382 that can be used to mate with a corresponding portion of themodular injector docking device. An embodiment of such a modularinjector docking device is shown in FIG. 24 .

In FIG. 24 , a modular injector docking device 400 is shown that cancomprise a body portion 402 and one or more prongs 404 extending fromthe body portion 402. The prongs 404 can taper toward tip portions 420thereof. The tip portions 420 can be used to contact the eye, asdiscussed below. In accordance with some embodiments, the prongs cancomprise an arcuate portion 406, which can be configured to match ormate against the surface of an eye.

The body portion 402 of the injector docking device 400 can comprise alumen 412 having an inner profile that matches an outer profile of theouter surface 382 of the sleeve 316. As shown in FIGS. 23 and 24 , theinner and outer profiles can be generally circular, thus allowing freerotation of the injector docking device 400 about the sleeve 316.However, other profiles can be used that limit or resist relativerotation between the injector docking device 400 and the sleeve 316. Forexample, triangular, square, or other polygonal shapes can be used.Additionally, one or more notches, grooves, or other surface featuresand corresponding notches, grooves and surface features can be formed inthe injector docking device 400 and the sleeve 316 in order to resist orprevent relative rotational movement between the injector docking device400 and the sleeve 316.

In use, the modular injector docking device 400 can be coupled to asleeve 316 of an injector 300, as shown in FIGS. 25 and 26 . Thesefigures illustrate another procedure for implanting an intraocular shuntinto an eye using an injector and the injector docking device shown inFIGS. 23 and 24 , according to some embodiments.

As shown in FIG. 25 , the modular injector docking device 400 can bepositioned against an eye 410. In accordance with some embodiments, theprongs 404 can be positioned such that the tip portions 420 of theprongs 404 are positioned adjacent to the corneal limbus 430 of the eye410. The tip portions 420 of the prongs 404 can be positioned adjacentto (e.g., posterior to, anterior to, or against) the corneal limbus. Forexample, in some embodiments, the tip portions 420 can be positionedwithin about 4 mm, about 3 mm, about 2 mm, about 1 mm, or against thecorneal limbus 430. However, the tip portions 420 can be placed at anysuitable location as required to achieve placement of the shunt withinthe desired target outflow region. As such, the surgeon can use fiducialmarkers of the eye to align or otherwise positioned the tip portions 420against the eye 410.

While maintaining the position of the injector docking device 400, thesurgeon can then advance the needle 310 into the eye 410. In doing so,the cooperation between the sleeve 316 and the injector docking device400 can allow the surgeon to carefully control the trajectory andplacement of the needle 310 within the eye 410.

The method illustrated in FIGS. 25 and 26 also illustrates that a bleb440 can be formed in the eye 410 prior to implantation of the shunt.However, as discussed herein, the bleb 440 can be formed after initialplacement of the shunt within the eye, thus allowing more precisevisualization for the surgeon in performing a procedure in which theinjector docking device is not coupled or removably affixed to the eye.

FIGS. 27-35D illustrate additional injector embodiments in which theinjector docking device and the injector are formed unitarily, coupledwith each other, or otherwise formed from a single, continuous housingor material to form a single handheld unit. Further, related shuntimplantation procedures are also illustrated.

Referring to FIGS. 27-29 , an injector 500 can be provided thatcomprises a housing 502 coupled directly with an injector docking device504. The injector docking device 504 can be co-molded or otherwisepermanently attached to the housing 502. In some embodiments, theinjector docking device and the injector housing can be formed from asingle, continuous piece of material. For example, the housing 502 cancomprise upper and lower halves or left and right halves in which aportion of each half defines sections of the injector docking device504.

The injector docking device 504 can comprise at least one eye-contactingportion that can be aligned with a fiducial marker of the eye and enablea surgeon to contact the injector docking device 504 against the eyeduring the implantation procedure. For example, in some embodiments, theinjector docking device 504 can comprise a ring-shaped structure similarto the injector docking device illustrated in FIGS. 6-10 and 32-35D.However, in some embodiments, such as that illustrated in FIGS. 27-29 ,the injector docking device 504 can comprise a partial-ring or half-ringcomponent or a structure having two or more contact portions that can bepositioned against the eye during the procedure. Further, in someembodiments, the half-ring component can comprise a vacuum pocket orchannel through which suction can be applied to removably couple theinjector docking device to the eye. The contact portions of thestructure, whether ring shaped or otherwise, can be used to facilitatealignment of the needle with the eye and provide guidance of the needleduring the implantation process.

In the embodiment shown, the injector docking device 504 can comprise anopposing arcuate, half-ring component 510 that can serve as a contactportion for initial alignment of the injector docking device 504 withthe eye. The injector docking device 504 can also comprise an opposingabutment portion 512 extending adjacent to an outlet 520 of a needle522, as shown in FIGS. 28 and 29 . The opposing abutment portion 512 canbe configured to contact the eye during the shunt delivery procedure.

In some embodiments, the half-ring component 510 and the opposingabutment portion 512 can be coupled together via a bridge 514. Thebridge 514 can comprise one or more (shown as two) elongate structuresthat interconnect portions of the half-ring component 510 and theopposing abutment portion 512 to maintain the half-ring component 510and the opposing abutment portion 512 in a spaced apart relationship. Inthis manner, the half-ring component 510 and the opposing abutmentportion 512 can be positioned on opposing or different portions of theeye, for example, around the cornea. Further, the bridge 514 cancomprise an aperture or targeting feature (such as the targeting ringnoted herein) that allows the surgeon to visually verify placement ofthe injector docking device 504 relative to the eye.

The half-ring component 510 and the opposing abutment portion 512 cancomprise contact surfaces that complement the external geometries of theeye, thereby facilitating placement of the injector docking device 504on the eye during the shunt delivery procedure.

In accordance with some embodiments, the half-ring component 510 and theopposing abutment portion 512 can each comprise surfaces that extendalong a spherical or ellipsoidal path. In some embodiments, thehalf-ring component 510 and the opposing abutment portion 512 can eachcomprise surfaces that extend along a common spherical or ellipsoidalpath. For example, the surfaces of the half-ring component 510 and/orthe opposing abutment portion 512 can be shaped to match the limbalcurvature of the eye. In some embodiments, the surfaces of the half-ringcomponent 510 and/or the opposing abutment portion 512 can have a radiusof curvature 144 (as noted above with respect to FIG. 10 ; the detailsof which can be the same and are not repeated here for brevity). In someembodiments, the surfaces of the half-ring component 510 and/or theopposing abutment portion 512 can have an annular or rounded shape thatcan be mated against the limbus between the cornea and the sclera.

Referring again to FIG. 28 , the housing 502 can extend along alongitudinal axis 540 and the injector docking device 504 can extendalong a longitudinal axis 542. The relative orientation of thelongitudinal axis 540 and the longitudinal axis 542 can advantageouslyenable a surgeon to reach any of the quadrants of the eye during theimplantation procedure. For example, the longitudinal axis 540 canextend transversely relative to the longitudinal axis 542. In someembodiments, the longitudinal axis 540 can extend transversely relativeto the longitudinal axis 542 at an angle 544 of between about 0 degreesand about 60 degrees, between about 20 degrees and about 50 degrees,between about 30 degrees and about 40 degrees, or about 35 degrees. Thisangular orientation can therefore provide easier access to differentquadrants of the eye.

Additionally, as shown in FIGS. 28 and 29 the injector docking device504 can comprise a neck section 548 along which the needle 522 can havea substantially straight path. For example, the needle 522 can extendalong a straight path along the longitudinal axis 544. Proximal to theneck section 548, the path of the needle 522 can curve slightly and thenthe needle path can follow a substantially straight path along thelongitudinal axis 540. The straight path of the needle 522 in the necksection 548 can advantageously assist the needle 522 in following astraight path as the needle 522 is advanced distally out of the necksection 548 during the implantation procedure.

In accordance with some methods, a shunt delivery procedure can beperformed using the injector docking device 504 for initial guidance byplacing one or both of the half-ring component 510 and the opposingabutment portion 512 against the eye, such as against at least a portionof the limbus. In some embodiments, the half-ring component 510 and theopposing abutment portion 512 can be placed into contact with the eyealong the limbus. However, in other embodiments, either the half-ringcomponent 510 or the opposing abutment portion 512 can be placed incontact with a left or right side of the limbus while the other of thehalf-ring component 510 or the opposing abutment portion 512 is spacedapart or tilted up from the eye. This initial contact can provideinitial confirmation to the surgeon and allow the injector 500 to beinitially guided to the target entry point in the eye.

Once the injector 500 has been placed in contact against the eye,whether one or both of the half-ring component 510 or the opposingabutment portion 512 are in contact with the eye, the surgeon can beginadvancing the needle tip portion toward the target entry point in theeye.

Referring now to FIGS. 30A-31C, an embodiment of a shunt deliveryprocedure is shown. As illustrated in FIGS. 30A-30C, the injector 500can be positioned against an eye 550 with the half-ring component 510positioned adjacent to or in contact with a right side 560 of thecorneal limbus of the eye 550. For example, the half-ring component 510can be positioned posterior to, anterior to, or against the corneallimbus. Further, a needle of the injector 500 is positioned adjacent toa target outflow area of the eye 550. In the illustrated embodiment, thehalf-ring component 510 can be positioned in a location opposite thetarget outflow region along the corneal limbus. The half-ring component510 can be used for initial guidance of the injector 500. When thehalf-ring component 510 is placed on the right side limbus 560, theinjector can be held or tilted up on the opposite side (i.e., on theleft side limbus 562). The injector 500 can then be slowly tilted backdown towards the left of the eye 550 until the needle tip portion 570comes close/touches the sclera 572 on the anticipated entry point (whichcould be marked beforehand for confirmation). As the needle tip portion570 reaches the sclera 572 (e.g., at the same time), the half-ringcomponent 510 can fully rest on the right side limbus 560.

In the starting position shown in FIGS. 30A-30C, the needle is now linedup (position and needle entry angle), and the surgeon can then prepareto push the needle into the eye along the straight final needle lengthsection. This may require a slight upwards angled push until theopposing abutment portion 512 comes to rest against the sclera 572, asshown in FIGS. 31A-31C.

In accordance with some embodiments, as the needle tip portion 570 ispushed in, the half-ring component 510 can move away from the eye 550and is no longer aligned or used. However, as discussed herein and withrespect to the embodiments shown in FIGS. 32-35D, some embodiments canbe implemented in which both the half-ring component 510 and theopposing abutment portion 512 are placed into initial contact with theeye 550 and maintain that same contact with the eye 550 throughout theimplantation procedure.

For example, in some embodiments, one or more portions of the injectordocking device 504 can comprise a transparent material that allows thesurgeon to see the needle location, angle, and path, thereby allowingthe surgeon to place the half-ring component 510 and the opposingabutment portion 512 can be in full contact with the eye 550 throughoutthe procedure. In some embodiments, in a pre-deployment position, theneedle tip portion 570 can be recessed into the neck section 548 (asshown in the embodiment of FIGS. 32-34 ) and, after the surgeon confirmsthat the needle path is proper through visualization through thetransparent injector docking device, the needle tip portion 570 could beadvanced distally through or beyond the opposing abutment portion 512.

The docking device of any of the embodiments disclosed herein can beformed from a transparent material. Further, the docking device can haveone or more markers, lines, or other indicia that can be used to alignthe injector docking device with the eye, such as the limbus, sclera,cornea, or other fiducial markers of the eye.

After the correct needle bevel position is confirmed visually (e.g.,through a microscope), the surgeon pushes a button or otherwise engagesa mechanism that automatically withdraws the needle while holding theshunt stationary within the eye 550. This can be done slowly or veryquickly (e.g., in less than about 0.5 seconds). It may be preferable, insome embodiments, to quickly withdraw the needle and release the shuntto minimize any eye movement. Once the needle has been removed from theeye 550, the injector 500 can be removed.

Thereafter, as discussed above and not repeated herein for brevity, thetarget outflow region can be ballooned in order to ensure that theoutflow end of the shunt is positioned within the target outflow region.For example, a bleb can be formed at the entry point of the needle toballoon the conjunctiva, intra-Tenon's adhesion space, or thesuprascleral space (and other spaces disclosed herein) to bring theoutflow end of the shunt into the respective space. Further, asdiscussed herein, the ballooned space or bleb can thereafter becarefully swiped down to lay the shunt 680 flat within the targetoutflow region, and proper shunt position in the target outflow regioncan be visually confirmed. If necessary, the position of the shuntoutflow end can be adjusted manually with forceps from outside of theeye 550.

Referring now to FIGS. 31D-31F, after the shunt 552 is released from theinjector, a distal or inflow portion of the shunt 552 can be positionedwithin the eye 550 while a proximal or outflow portion of the shunt 552initially extends outside of a target outflow region. For example, theoutflow portion of the shunt 552 can be positioned within or outside ofthe eye 550 prior to subsequent repositioning within the target outflowregion. As discussed below, a bleb can be formed within the targetoutflow region in order to balloon the target outflow region around theoutflow portion of the shunt 552. By forming a bleb or ballooning thetarget outflow region, the target outflow region can be manipulated inorder to encapsulate or reposition the outflow portion of the shunt 552within a target outflow region of the eye 550.

Further, although the present procedure is illustrated with regard tothe inserter 500, any of the embodiments of injector docking devices orinjectors can be implemented to perform the initial placement of theshunt within the eye in preparation for bleb formation after the shunthas been released into the eye 550.

For example, referring to FIG. 31D, placement of a shunt 552 isillustrated such that an inflow end 555 of the shunt 552 is positionedin a final target position within the eye 550. In some embodiments, theinflow end 555 of the shunt 552 is positioned in a region of higherpressure in the eye (e.g., the anterior chamber 554) and an outflow end557 of the shunt 552 is positioned outside of the eye 550 such that theshunt 552 extends through the sclera 556 and conjunctiva 558.

Referring to FIG. 31E, after the shunt 552 has been placed and has beendetermined to be properly engaged with the eye tissue (e.g., with agelatin shunt, a clinician can wait a set period of time for the shuntto hydrate and expand within the eye tissue to reduce shunt migration),the target outflow region can be ballooned. Bleb formation can beperformed by using a syringe 562 or other tool to inject an amount of aBSS, lidocaine, viscoelastic, and/or healon mixture into the targetoutflow region. In FIG. 31E, the target outflow region is illustrated asthe subconjunctival space. As the bleb 560 is formed, and with the shunt552 secured within the underlying eye tissue, the conjunctiva 558overlying the target outflow region moves proximally toward the outflowend 557 of the shunt 552 until the outflow end 557 of the shunt 552 isswallowed or encapsulated within the eye, as shown in FIG. 31F. Theoutflow end 557 can be further manipulated in order to position orensure positioning of the outflow end 557 within the target outflowregion. Thereafter, the ballooned space or bleb 560 can be swiped down(e.g., deep to the conjunctiva 558) to lay the shunt 552 flat within thetarget outflow region.

Referring now to FIGS. 32-35D, an injector 600 can be provided havingvarious features similar to those discussed above with regard to theinjector 500. One of the differences is that the injector 600 can havean injector docking device 604 comprising a ring-shaped structure thatcan be maintained in contact with an eye 608 throughout the shuntimplantation procedure. Further, the injector docking device 604 canalso comprise a vacuum or suction mechanism similar to that discussedabove with respect to the embodiment shown in FIGS. 3A-7 .

Referring to FIGS. 32-34 , the injector 600 can comprise a housing 602and a neck section 606. The housing 602 can extend along a longitudinalaxis 610 that extends transverse relative to a longitudinal axis 612 ofthe neck section 606 of the injector docking device 604. As noted abovewith regard to the embodiment shown in FIGS. 28-30 , the relativeorientation of the longitudinal axes 610, 612 of the housing 602 and theneck section 606 can advantageously enable a surgeon to reach any of thequadrants of the eye during the implantation procedure. For example,longitudinal axes 610, 612 of the housing 602 and the neck section 606can extend transversely relative to each other at an angle 544 ofbetween about 0 degrees and about 60 degrees, between about 20 degreesand about 50 degrees, between about 30 degrees and about 40 degrees, orabout 35 degrees. This angular orientation can therefore provide easieraccess to different quadrants of the eye.

Further, as shown in FIG. 32 , the neck section 606 of the injectordocking device 604 can support a needle 620 along a substantiallystraight path. For example, the needle 620 can extend along a straightpath along the longitudinal axis 612. Proximal to the neck section 606,the path of the needle 620 can curve slightly and then the needle pathcan follow a substantially straight path along the longitudinal axis610. The straight path of the needle 620 in the neck section 606 canadvantageously assist the needle 620 in following a straight path as theneedle 620 is advanced distally out of the neck section 606 during theimplantation procedure.

Referring now to FIG. 34 , the injector docking device 604 can comprisea ring-shaped structure 630 having an eye-contacting surface 632 thatcomplements the external geometries of the eye, thereby facilitatingplacement of the injector docking device 604 on the eye during the shuntdelivery procedure. The eye-contacting surface 632 of the ring-shapedstructure 630 can be configured to extend along a majority of thecorneal limbus when positioned against the eye. In some embodiments, theeye-contacting surface 632 can be positioned adjacent to the corneallimbus. For example, the eye-contacting surface 632 can be positionedposterior to, anterior to, or against the corneal limbus.

The eye-contacting surface 632 of the ring-shaped structure 630 can havea concave shape and extend along a spherical or ellipsoidal path. Theeye-contacting surface 632 can be shaped to match the scleral curvatureof the eye. In some embodiments, the radius of curvature of theeye-contacting surface 632 can approximate the radius of curvature ofthe sclera of the eye in order to better mate against the sclera. Forexample, the eye-contacting surface 632 can have a radius of curvature144 of between about 11 mm and about 14 mm, between about 11.6 mm andabout 13.4 mm, between about 11.9 mm and about 12.9 mm, or about 12.4mm. The radius of curvature can fall within acceptable ranges of theradius of curvature of the sclera, as known in the art or measured usingknown methods, as discussed above.

In some embodiments, the ring-shaped structure 630 can have an annularor rounded shape having an inner diameter 640 that allows thering-shaped structure 630 can be mated against the limbus between thecornea and the sclera. For example, the inner diameter 640 can bebetween about 11 mm and about 14 mm, between about 12 mm and about 13.5mm, or about 13 mm. Accordingly, in some embodiments, the ring-shapestructure 630 can be sized to fit around a limbus of an eye withoutcontacting or having substantial contact with the limbus.

Additionally, the eye-contacting surface 632 can be configured to becoupled to or removably affixed to the eye 608. As noted above in otherembodiments, the injector docking device 604 can provide suction onand/or otherwise engage the cornea and/or below corneal limbus (e.g.,along the sclera). An alternative to suction is to provide a frictionalor grippy surface, such as ridges, hooks, or spikes that may penetrateor otherwise engage the conjunctiva. Such a surface can enable thesurgeon to contact the injector docking device 604 against the eye andachieve suitable frictional and/or mechanical engagement with the eye.However, suction and mechanical engagement can both be used in someembodiments.

For example, as shown in FIG. 34 , the eye-contacting surface 632 can beformed to include a vacuum pocket or channel 660. The vacuum pocket 660,similar to the other vacuum pocket's discussed herein and otherembodiments, can allow the ring-shaped structure 630 of the dockingportion 604 to engage or be removably affixed to the eye 608 during theimplantation procedure. A corresponding vacuum port can be positioned ateither a first or second end 662, 664 of the vacuum pocket and be influid communication with a channel and vacuum source via the housing 602of the injector 600.

As also illustrated FIGS. 33 and 34 , the ring-shaped structure 630 cancomprise a gap or opening 670 through which the needle 620 can pass. Inthis manner, with the eye-contacting surface 632 positionable below thelimbus of the eye 608, the needle 620 can enter the eye 608 at alocation below the limbus, as generally shown in FIG. 32 . The opening670 can extend along less than about ¼, less than about ⅕, less thanabout ⅙, less than about 1/7, less than about ⅛, less than about 1/9,less than about 1/10, or less than about 1/12 of the circumference ofthe ring-shape structure 630.

In some embodiments, in a pre-deployment position, the needle 620 can berecessed into the neck section 606 and, after the surgeon confirms thatthe needle path is proper, the needle 620 could be advanced distallythrough or beyond the opening 670 and into the eye 608. However, in apre-deployment position, the needle 620 can also extend into the opening670. Nevertheless, in order to ensure that the needle 620 does notcontact the eye 608 when the eye-contacting surface 632 is firstpositioned against the eye 608, the needle 620 should not extend intothe opening 670 beyond the eye-contacting surface 632 (e.g., beyond acurved plane having a radius of curvature that approximates that of theeye-contacting surface 632).

In accordance with some methods, a shunt delivery procedure can beperformed using the injector 600 and the injector docking device 604.Such procedures are very similar to those discussed above with respectto the injector 500, except that the ring-shape structure 630 of theinjector docking device 604 extends almost all the way around the limbusand can be affixed to the eye (e.g., via suction and/or mechanicalengagement).

As shown in FIG. 35A, the needle 620 is inside the neck portion 606 andthe ring-shape structure 630 is fully engaged around the limbus 672 ofthe eye 608. In the embodiment shown in FIGS. 35A-35D, the targetoutflow region 674 (here shown as the subconjunctival space) has alreadybeen ballooned and a bleb has been formed. However, as noted above, someembodiments can be performed in which the target outflow region 674 isballooned after the shunt has been placed in the eye.

Referring to FIG. 35B, the needle 620 can be advanced out of theinjector housing 602 (neck portion 606). The needle 620 preferably comesout straight at the shown angle, as discussed above, but could also comeout in a slight curve to allow for a longer channel within the sclera676. As noted above, the conjunctival or scleral entry point can be atabout 4 mm, about 3 mm, or about 2 mm below the limbus. The needle 620can be advanced through the target outflow region 674, the conjunctiva,sclera 676 and into the anterior chamber angle. The needle 620 carries apreloaded shunt 680 with it and the pusher rod 682 behind the shunt 680.The advancement of the needle 620 can be done either through actuationof a button or a slider, and may be manual or use an energy storedmechanism (e.g., spring loaded actuation, electrical motor, or magneticmovement).

The surgeon can verify that the shunt 680 is properly positioned withinthe eye. For example, the surgeon can visually verify, through asurgical microscope, for example, that a bevel of the needle 620 isvisible inside the eye. As shown in FIGS. 35C and 35D, after the shunt680 is properly positioned within the eye, the surgeon can activatewithdrawal of the needle 620 while holding the pusher rod 682 in place.This withdrawal can be done either through actuation of a button or aslider, and may be manual or use an energy stored mechanism (e.g.,spring loaded actuation, electrical motor, or magnetic movement). Theshunt 680 is thereby left in its final position, as shown in FIG. 35D.

At this point, the injector 600 can be removed from the eye 608.Thereafter, as discussed above and not repeated herein for brevity, ifnecessary, the target outflow region 674 can be ballooned in order toensure that the outflow end of the shunt 680 is positioned within thetarget outflow region 674. For example, a bleb can be formed at theentry point of the needle to balloon the conjunctiva, intra-Tenon'sadhesion space, or the suprascleral space (or other spaces disclosedherein) to bring the outflow end of the shunt 608 into the respectivespace. Further, as discussed herein, the ballooned space or bleb canthereafter be carefully swiped down to lay the shunt 680 flat within thetarget outflow region, and proper shunt position in the target outflowregion can be visually confirmed. If necessary, the position of theshunt outflow end can be adjusted manually with forceps from outside ofthe eye 550.

Surgery Steps in Some Embodiments

The following discussion provides a variety of steps that can beperformed in ab externo methods for injecting a shunt or stent into atarget outflow region of the eye. Advantageously, the shunt can beinjected into the temporal superior, temporal inferior, nasal superior,or nasal inferior quadrants in order to provide a conduit or outflowpathway from a region of higher pressure to a region of lower pressure,such as from the anterior chamber to any of the target outflow regionsdiscussed herein. Advantageously, using some embodiments of thisprocedure, a shunt can be more easily placed in every quadrant of theeye (compared to ab interno approaches) since the injector needle nolonger has to go across the entire anterior chamber. These steps can beperformed using a “guided” procedure or a “freehand” procedure.

The following discussion provides a variety of actions that can beperformed in carrying out some of the embodiments of the proceduresdisclosed herein. Not all of the following actions are required to beperformed in some embodiments, and the following actions may take placein a different order, according to some embodiments. Thus, the presenceof a specific action or its specific position in the list of possibleactions are not an indication that such an action is required or thatsuch an action must be performed prior to or after another given action.

When using an injector docking device, a surgeon can first measure theeye or confirm that the eye is within a size range and chose a ring orconfirm that a given ring is the correct size for the patient. In someembodiments, the injector docking device can fit a range of eye sizes(based on corneal diameter), and in some embodiments, a single injectordocking device can fit all eyes.

Step 1. Optionally, the surgeon can inject an antimetabolite into thetarget outflow region to open the target outflow region (e.g.,subconjunctival space or other spaces disclosed herein), and wait forthe antimetabolite to dissipate.

Step 2. Optionally, a BSS, lidocaine, viscoelastic, and/or healonmixture can be injected into a target outflow region (e.g., thesubconjunctival space or other spaces disclosed herein) from about 2 mmto about 10 mm away of the planned shunt outflow location, to create aballooned volume. The shunt can be injected into this created space.However, the injection of a mixture into the target outflow region canalso be performed after the shunt is injected into the eye, as discussedherein. The exact level or layer (as necessitated by the target outflowregion) of injection location can be controlled and can determine theshunt level position (e.g., sub-Tenon's, intra-Tenon's, or over-Tenon's,but still under the top conjunctival layer). The conjunctival entry holecan be closed with a suture or fibrin glue if desired, although the highmetabolism of the conjunctiva can close the hole rapidly, such as withinan hour of use.

Step 3. Optionally, for easier and straighter shunt placement in asubconjunctival location, the surgeon can perform a small local Tenonadhesion dissection in the area of the planned shunt placement. Such alocal dissection can be done using a small gauge needle (e.g., 27 G or30 G) or small knife. The needle or knife can be inserted into thetarget outflow region (e.g., subconjunctival space or other spacesdisclosed herein) from a few millimeters away (e.g., between about 2 mmto about 10 mm) at a shallow angle (e.g., just like when performing asubconjunctival injection). The needle can then be moved sideways whilesliding on the top sclera layer and can thereby cut off the Tenonadhesion to the sclera in that area. This step is optional, but if donecan be easily combined with the injection in step 2 using the very sameneedle. In some embodiments, the surgeon can inject first and then moveneedle sideways to cut adhesions on the bottom of the ballooning.Alternatively, the surgeon can inject and move simultaneously. Theconjunctival entry hole can be closed with a suture or fibrin glue ifdesired, although the high metabolism of the conjunctiva can close thehole rapidly, such as within an hour of use.

Step 4. If used, an injector docking device (using a targeting ring orother means) can be visually centered on the eye while aligning theinjector guidance port near the nasal superior quadrant or otherquadrant, as necessary. The surgeon can use markers and/or otherguidance features for good alignment or automated vision systems toprovide feedback or guidance to the surgeon.

Step 5. If necessary, the patient should be instructed to look temporalinferior (if orienting the injector docking device injector guidanceport near the nasal superior quadrant) or other quadrant opposite theposition of the injector guidance port, as necessary.

Step 6. Optionally, if using an injector docking device, surgeon canreach maximum high superior placement position, if desired, by rotatingneedle port of injector docking device to maximal superior position onthe nasal side while maintaining clearance for injector. Otherwise,maximum clearance for the injector can be achieved by appropriateplacement of the needle port.

Step 7. Optionally, if using an injector docking device, the surgeon canverify that the target outflow region ballooned volume is larger thanthe bleb pocket space in injector docking device. This can be visuallyverified by the creation of visibility of excess target outflow regionballooning around the pocket space of the injector docking device.

Step 8. Optionally, if using an injector docking device, the surgeon cansecure or engage the injector docking device to the eye (e.g., bydrawing vacuum on injector docking device or couple the ring to the eyeusing frictional coupling mechanism of the injector docking device). Insome embodiments, the injector docking device may not be removably fixedor coupled to the eye, but may instead be abutted or positioned againstthe eye to provide a desired spacing of the injector relative to the eyeor a desired entrance angle for the needle into the eye.

Step 9. If using an injector docking device, the surgeon can insert theinjector all the way to the injector guidance port of the injectordocking device until contacting the internal shoulder or stop of theinjector guidance port. The sleeve of the injector can be positioned atthe most forward part (i.e., the needle can be retracted into thesleeve), at this point. Alternatively, the needle could protrude beyondthe sleeve when the injector is inserted into the injector guidanceport, and the entire injector can be moved towards the eye while undersleeve-port guidance and the needle penetrates all layers as describedin step 10.

Step 10. The needle can be actuated to move needle through conjunctiva,Tenon's capsule, sclera, and the anterior chamber angle tissue layersand into the anterior chamber. In some embodiments, this is done whilethe needle is fully guided by the guidance port of the injector dockingdevice. In some embodiments, the shunt and pusher rod behind the shuntwill move forward with the needle inside of it. In some embodiments, theconjunctival or scleral entry point can be at about 4 mm, about 3 mm, orabout 2 mm below the limbus.

Step 11. The surgeon can then verify that the needle tip is visible inangle to ensure that an inflow end of the shunt is or can be positionedwithin the anterior chamber.

Step 12. If necessary, the surgeon can inject additional BSS, lidocaine,viscoelastic, and/or healon mixture if necessary to balloon or inflatethe target outflow region or re-inflate the already-ballooned targetoutflow region.

Step 13. If necessary, the surgeon can continue actuation of theinjector to advance the shunt to its final position with the inflow andthereof in the anterior chamber and the outflow end thereof in thetarget outflow region. Surgeon can also verify that the inflow end ofthe shunt is positioned in anterior chamber.

Step 14. The surgeon can then retract the needle while the shunt is keptstationary in the final position (relative to the eye), for example,using a pusher rod behind the shunt proximal end inside the needle.Thereafter, the pusher rod can be retracted.

Step 15. If using an injector docking device, the surgeon can removeinjector docking device.

Step 16. Optionally, the surgeon can massage the bleb away from corneatowards position of shunt (e.g., massage or lay the shunt down towardsthe deep layer of the target outflow region). The massaging can alsomove the shunt outflow position away from the conjunctival needlepuncture and therefore reduce the chance for a subsequent leakage ofaqueous humor). Thus, massaging the bleb can reposition the shuntoutflow end to a desired position within the target outflow region.

Several variations of the above sequence are possible and can be used todeploy the shunt outflow end into any of the various spaces disclosedherein. Additionally, some embodiments of the procedure can be performedunder guidance.

Further, some embodiments of the procedure, especially those using theinjector docking device, can be performed in an office setting ratherthan a full sterility controlled or operating room setting, as long asall parts that touch the eye are fully sterile before use (e.g.sterilized disposables).

However, if the surgery is done in an operating room, an injectordocking device may be unnecessary. In that case, the surgeon canapproach freehand through the conjunctiva and sclera similar to theneedle track they already do for the Ahmed or Baerveldt tube shuntplacements. In accordance with some embodiments, the sleeve of theinjector can be dimensioned to act as the longitudinal placementreference/stopper as it stops on the outside of the eye (conjunctivaover sclera). For example, such embodiments are discussed further below.

The ballooning of the eye can be done as a first step as described aboveor in another variation, the surgeon can place the shunt ab externowithout the injector docking device and without ballooning. In such aprocedure, after the shunt is released and the injector is removed, theoutflow end of the shunt would protrude out of the eye through theconjunctiva while the inflow end of the shunt is positioned within theanterior chamber. The surgeon could then balloon the conjunctiva aroundthe shunt outflow end until the conjunctiva and target outflow regionwould fully engulf the shunt outflow end such that the shunt is fullyinside the newly formed bleb. At that point, the bleb can be pushed downand thereby laying the shunt flat against the sclera, as describedabove.

Different target outflow regions can be ballooned, as noted above and asshown in FIGS. 36A-38C. For example, FIGS. 36A, 37A, and 38A illustrateexamples of the target outflow regions in their ballooned states. FIG.36A illustrates ballooning of the subconjunctival space 60, FIG. 37Aillustrates ballooning of the intra-Tenon's adhesion space 11, and FIG.38A illustrates ballooning of the suprascleral space 61. Following aprocedure similar to that noted above, each of these spaces shown inFIGS. 36A-38A, as well as other spaces noted herein, can be inflated byan injection from a needle bevel is positioned adjacent to or within thespace.

Thereafter, as illustrated in FIGS. 36B, 37B, and 38B, a docking device100 can be positioned over a bleb created by the injection and inflationof the respective space. Once in position, an injector 220 can deliverand release a shunt 230 into the eye with a distal or inlet end of theshunt positioned in the anterior chamber and a proximal or outflow endof the shunt positioned in the respective space, which is the targetoutflow region. Finally, as shown in FIGS. 36C, 37C, and 38C, aftermanual and/or eventual diffusion and deflation of the bleb, the outflowend of the shunt can be positioned within the subconjunctival space 60,the intra-Tenon's adhesion space 11, and the suprascleral space 61,respectively. As noted herein, the target outflow region can include anyof the several spaces disclosed herein other than those shown in FIGS.36-38C. For example, some methods can involve forming a bleb in othertarget outflow regions or potential spaces in order to facilitateplacement of the outflow end of the shunt thereat, including thesubconjunctival space or over-Tenon's space (between Tenon's andconjunctiva), the suprascleral or sub-Tenon's space (between Tenon's andsclera), the intra-Tenon's space (between layers of Tenon's capsule, orin the intra-Tenon's adhesion space), the choroidal and suprachoroidalspace, the intrascleral space (between layers of sclera), Schlemm'scanal, the vitreous space, the episcleral vein, or the supraciliaryspace.

Shunt Materials

In some embodiments, the material selected for the shunt can be agelatin or other similar material. For example, a gelatin used formaking the shunt can be a gelatin Type B from bovine skin. A preferredgelatin is PB Leiner gelatin from bovine skin, Type B, 225 Bloom, USP.Another material that may be used in the making of the shunts is agelatin Type A from porcine skin, also available from Sigma Chemical.Such gelatin is available is available from Sigma Chemical Company ofSt. Louis, Mo. under Code G-9382. Still other suitable gelatins includebovine bone gelatin, porcine bone gelatin and human-derived gelatins. Inaddition to gelatins, microfistula shunt may be made of hydroxypropylmethylcellulose (HPMC), collagen, polylactic acid, polyglycolic acid,hyaluronic acid and glycosaminoglycans.

If a gelatin shunt is used, the delivery of the shunt can be performedby wetting an inside the hollow shaft of the delivery device with abalanced salt solution (e.g., Dulbecco's Phosphate Buffered Saline), asteroid, or other drug prior to implantation. Such priming ensures thatthe shunt remains flexible before implantation. Further, an amount of aBSS, steroid, or other drug can be optionally injected through thehollow shaft, and in some embodiments, through the implant, into atarget space to create a primed space for outflow and to deliver a drug,such as an antifibrotic to that new drainage space.

The shunt material can be cross-linked. For example, when a gelatin isused, cross-linking can increase the inter- and intramolecular bindingof the gelatin substrate. Any means for cross-linking the gelatin may beused. In some embodiments, the formed gelatin shunts can be treated witha solution of a cross-linking agent such as, but not limited to,glutaraldehyde. Other suitable compounds for cross-linking include1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC). Cross-linking byradiation, such as gamma or electron beam (e-beam) may be alternativelyemployed.

Drug-Eluting Shunts

In accordance with some embodiments, the shunt can comprise a drug ordrug-eluting portion for drug delivery to one or more target locationswithin the eye. A drug-eluting portion can be provided in combinationwith any of the embodiments disclosed or taught herein. Therefore, someembodiments also relate to administering a pharmaceutical or drug viaimplantation of a shunt or plug, as discussed herein, to any of thevariety of target locations discussed herein.

For example, any of the shunts or systems disclosed herein can bemodified to incorporate a drug-eluting portion. Thus, some embodimentsprovide a shunt that also operates as a drug delivery device inside theeye.

In some embodiments, at least a section of the shunt can comprise one ormore drugs to provide a drug-eluting portion. In some embodiments, oneor more drugs can be provided along the entire length of the shunt.However, in some embodiments, one or more drugs can be provided alongless than the entire shunt or along only a portion of the shunt.

For example, a drug can be integrated into only one of the ends of theshunt to provide a single drug-eluting end which can be placed into theanterior chamber or location of lower pressure. Further, other thanbeing formed along an end of the shunt, the drug-eluting portion canalso be formed along an intermediate portion of the shunt. Accordingly,embodiments can provide a targeted drug release inside the anteriorchamber, inside the sclera, and/or in the subconjunctival space or othertarget drainage location, depending on the location and configuration ofthe drug-eluting portion(s).

In some embodiments, the shunt can comprise multiple drug-elutingportions, which can each be formed to provide different dissolving timesand/or have different drugs embedded therein. Accordingly, in someembodiments, two or more drugs can be delivered simultaneously onindependent release timings.

For example, the shunt can comprise multiple dissolvable sections, whichcan each be formed to provide different dissolving times and/or havedifferent drugs embedded therein.

Further, in some embodiments, the shunt can be impregnated or coatedwith one or more pharmaceutical and/or biological agents, e.g., drugs,biologics, pharmaceuticals, and/or other chemicals. The agent may beselected to regulate the body's response to the implantation of theshunt and the subsequent healing process. The agent can be carried bythe shunt for delivery to the target location(s).

The impregnation and/or coating of the agent can be completely orpartially along an interior or exterior portion of a shunt. In someembodiments, the pharmaceutical and/or biological agent may coat and/orimpregnate an entire exterior of the shunt, an entire interior of theshunt, or both. Alternatively, the pharmaceutical and/or biologicalagent may coat and/or impregnate a portion of an exterior of the shunt,a portion of an interior of the shunt, or both.

In some embodiments in which the agent is impregnated into the shunt,the shunt itself can be partially or completely dissolvable. Byincluding the biologics, pharmaceuticals, drugs, or other chemicals inthe liquid gelatin, the formed shunt will be impregnated with thebiologics, pharmaceuticals, drugs, or other chemicals.

As noted above, whether the agent is impregnated into and/or coated ontothe body of the shunt, the drug-eluting dissolvable portion(s) canextend along the entire length or only a portion of the length of theshunt.

Further, in some embodiments, a time-release or controlled-release drugcan be provided by means of an impregnated portion or coating to providea desired dissolution rate. Such drug-eluting portion(s) of the shuntcan provide a drug delivery, even without aqueous flow.

For example, some methods can comprise treatment with a drug orpharmaceutical, such as by implanting an intraocular shunt that has beencoated and/or impregnated with a pharmaceutical and/or biological agent,by treating the eye topically with a pharmaceutical and/or biologicalagent, and/or by injecting a pharmaceutical and/or biological agent intothe anterior chamber and/or a target outflow region, including anytarget outflow regions discussed or referenced herein, prior to or afterreleasing a shunt from the device. Suitable agents may include, forexample, any of those disclosed in the following U.S. Pat. Nos.8,785,394; 8,062,657; 7,799,336; 7,790,183; 7,033,605; 6,719,991;6,558,686; 6,162,487; 5,902,283; 5,853,745; and 5,624,704; and U.S.Patent Publication No. 2008/0108933; the content of each of thesereferences is incorporated by reference herein its entirety. Furtherexamples of suitable agents include anti-mitotic pharmaceuticals such asMitomycin-C or 5-Fluorouracil, anti-VEGF (such as Lucentis, Macugen,Avastin, VEGF or steroids), anti-coagulants, anti-metabolites,angiogenesis inhibitors, steroids, anti-inflammatories, antibiotics,brimonidine, timolol, prostaglandin analogs (such as travoprost,latanoprost, and tafluprost), prostamides (such as bimatoprost),cyclosporin, pilocarpine, corticosteroids and other steroid derivatives(such as hydrocortisone, dexamethasone, beclomethasone dipropionate,triamcinolone, triamcinolone acetate, cortisol benzoate), or otheragents for treating conditions of the eye, such as glaucoma, dry eye,allergy, or conjunctivitis, to name a few.

Aspects related to embodiments of drug delivery shunts are discussed inco-pending U.S. Application Publication No. 2012/0197175, filed on Dec.8, 2008, U.S. Application Publication No. 2014/0236066, filed on Feb.19, 2013, the entireties of each of which is incorporated herein byreference.

A drug-eluting shunt implementing any of the features discussed orreferenced herein can be implanted into any area of the eye to achievedrainage into any of the target areas discussed or referenced orreferenced herein. For example, the shunt can be implanted into thesuprachoroidal space (with one end in the anterior chamber and the otherend in the suprachoroidal space or with the entire shunt beingcompletely suprachoroidal) with the ability to deliver drugs at eitheror both ends or along an intermediate portion thereof. Some methods canbe implemented such that multiple shunts (with the same or differentdrugs and with the same or different release timings) can be implantedin different places (e.g., the subconjunctival space, the suprachoroidalspace, the anterior chamber, etc.). Other methods and procedures can beperformed to incorporate any of the shunts discussed or referencedherein. Further, additional procedures for delivering drug-eluting plugsor shunts within the eye can be performed using one or more of thesystems or devices disclosed herein. For example, the present disclosurecan be used in combination with any of the shunts, plugs, or methodsdisclosed in copending U.S. Patent Application No. 62/344,899, filedJun. 2, 2016, the entirety of which in incorporated herein by reference.

As used herein, “controlled release” or “time-release” may refer to therelease of an agent such as a drug from a composition or dosage form inwhich the agent is released according to a desired profile over anextended period of time. For example, such release can effect deliveryof an active over an extended period of time, defined herein as beingbetween about 60 minutes and about 2, 4, 6, 8 or even 12 hours.Controlled release profiles may include, for example, sustained release,prolonged release, pulsatile release, and delayed release profiles.Controlled release may also be defined functionally as the release ofover 80 to 90 percent (%) of the active ingredient after about 60minutes and about 2, 4, 6 or even 8 hours. Controlled release may alsobe defined as making the active ingredient available to the patient orsubject regardless of uptake, as some actives may never be absorbed bythe animal.

In contrast to immediate release compositions, controlled releasecompositions may permit delivery of an agent to a subject over anextended period of time according to a predetermined profile. Suchrelease rates can provide therapeutically effective levels of agent foran extended period of time and thereby provide a longer period ofpharmacologic or diagnostic response as compared to conventional rapidrelease dosage forms. Such longer periods of response may provide manybenefits that are not achieved with the corresponding short acting,immediate release preparations.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

The subject technology is illustrated, for example, according to variousaspects described below. Various examples of aspects of the subjecttechnology are described as numbered clauses (1, 2, 3, etc.) forconvenience. These are provided as examples and do not limit the subjecttechnology. It is noted that any of the dependent clauses may becombined in any combination, and placed into a respective independentclause, e.g., Clause 1 or Clause 13. The other clauses can be presentedin a similar manner.

Clause 1. An injector docking device for placing an intraocular shuntinto an eye, the device comprising: a needle support component havingproximal and distal portions and a longitudinal needle axis extendingbetween the proximal and distal portions, the support component beingconfigured such that, when coupled to an intraocular shunt inserter, theproximal or distal portion supports the inserter to align a needle ofthe inserter with the longitudinal needle axis; and an eye-contactingsurface disposed on the distal portion of the needle support component,the eye-contacting surface being positionable against the eye to permita clinician to align the device relative to an indicium of the eyethereby aligning the needle relative to the eye.

Clause 2. The docking device of Clause 1, wherein the eye-contactingsurface comprises at least one arcuate surface for alignment of thedocking device relative to an indicium of the eye and alignment of theneedle axis to the eye.

Clause 3. The docking device of Clause 2, wherein the eye-contactingsurface is at least partially concave.

Clause 4. The docking device of the preceding Clauses, wherein thedocking device comprises a body width that increases from the proximalportion to the distal portion.

Clause 5. The docking device of the preceding Clauses, wherein thedistal portion flares outwardly.

Clause 6. The docking device of the preceding Clauses, wherein theeye-contacting surface extends proximally from the distal portion towardthe proximal portion.

Clause 7. The docking device of the preceding Clauses, wherein theeye-contacting surface extends from an arcuate edge of the distalportion, the arcuate edge being positionable adjacent to a corneallimbus of the eye for aligning the device relative to the eye.

Clause 8. The docking device of the preceding Clauses, wherein theeye-contacting surface extends proximally from a distal end of theneedle support component.

Clause 9. The docking device of the preceding Clauses, wherein thedistal portion comprises a ring-shaped component.

Clause 10. The docking device of the preceding Clauses, wherein thedistal portion comprises a half-ring component.

Clause 11. The docking device of the preceding Clauses, wherein whencoupled with the inserter, the needle of the inserter is coaxial withthe longitudinal needle axis.

Clause 12. The docking device of the preceding Clauses, wherein thesupport component is detachable from an intraocular shunt inserter.

Clause 13. The docking device of the preceding Clauses, wherein thesupport component surrounds at least a portion of the needle.

Clause 14. The docking device of the preceding Clauses, wherein theneedle support component comprises an elongate shaft and a needle portextending therethrough.

Clause 15. The docking device of Clause 14, wherein the needle portextends through the eye-contacting surface.

Clause 16. The docking device of the preceding Clauses, wherein theneedle axis extends through the eye-contacting surface.

Clause 17. The docking device of the preceding Clauses, whereineye-contacting surface comprises a blunt face positionable against theeye, the blunt face having a surface area of at least about 5 mm2.

Clause 18. The docking device of the preceding Clauses, whereineye-contacting surface comprises a blunt face positionable against theeye, the blunt face having a surface area of at least about 10 mm2.

Clause 19. The docking device of the preceding Clauses, whereineye-contacting surface comprises a single, continuous surface throughwhich the needle axis passes.

Clause 20. The docking device of the preceding Clauses, wherein aportion of the needle support component is transparent to facilitatevisualization of the needle or an indicium of the eye.

Clause 21. The docking device of Clause 1, further comprising an annularbody coupled to the needle support component, the annular bodycomprising the eye-contacting surface.

Clause 22. An injector docking device for placing an intraocular shuntinto an eye, the device comprising: an annular body; an eye-contactingportion formed on a first side of the annular body, the eye-contactingportion extending about a central axis of the body; and a needle supportcomponent extending from the annular body, the needle support componentcomprising a needle port, the needle port defining a needle axisextending toward the eye-contacting portion.

Clause 23. An injector docking device for placing an intraocular shuntinto an eye, the docking device comprising: an arcuate body comprisingan eye-contacting portion formed on a first side of the arcuate body;and a needle support component coupled to the arcuate body, the needlesupport component comprising a needle port, the needle port defining aneedle axis extending toward the eye-contacting portion.

Clause 24. The docking device of Clause 23, wherein the arcuate bodycomprises an annular structure.

Clause 25. The docking device of any of Clauses 23-24, wherein thearcuate body comprises first and second components.

Clause 26. The docking device of Clause 25, wherein the first and secondcomponents are coupled together via a bridge, the first component spacedapart from the second component, the first component comprising asemicircular shape.

Clause 27. The docking device of Clause 26, wherein the needle axisextends through the second component toward the first component.

Clause 28. The docking device of any of Clauses 26-27, wherein theneedle axis does not intersect with the bridge.

Clause 29. The docking device of any of Clauses 23-28, wherein theeye-contacting portion comprises a scleral contact surface and a cornealcontact surface, the scleral contact surface defining a first radius ofcurvature, the corneal contact surface defining a second radius ofcurvature different than the first radius of curvature.

Clause 30. The docking device of Clause 29, wherein the first radius ofcurvature is greater than the second radius of curvature.

Clause 31. The docking device of any of Clauses 29-30, wherein thescleral contact surface and the corneal contact surface meet at a limbusridge, the limbus ridge comprising a circular protrusion extending in adirection away from the eye-contacting portion.

Clause 32. The docking device of any of Clauses 23-31, wherein theneedle support component comprises a shaft having the needle portextending therethrough, the needle port comprising a lumen within theshaft.

Clause 33. The docking device of any of Clauses 23-32, wherein theeye-contacting portion comprises an adhesion component for coupling theinjector docking device to the eye.

Clause 34. The docking device of Clause 33, wherein the adhesioncomponent comprises a plurality of spikes.

Clause 35. The docking device of any of Clauses 33-34, wherein theadhesion component comprises a channel for applying vacuum pressure to asurface of the eye.

Clause 36. The docking device of Clause 35, wherein the channel extendsalong a scleral contact surface of the body.

Clause 37. The docking device of any of Clauses 35-36, wherein thechannel extends along a corneal contact surface of the body.

Clause 38. The docking device of any of Clauses 35-37, furthercomprising a vacuum port in fluid communication with the channel, thevacuum port extending from an upper portion of the body opposite thefirst side.

Clause 39. The docking device of any of Clauses 23-38, wherein thearcuate body extends about a central axis, and wherein needle axisextends at an angle of between about 48 degrees to about 98 degrees withrespect to the central axis.

Clause 40. The docking device of any of Clauses 23-39, wherein thearcuate body extends about a central axis, and wherein the needle axisextends at an angle of between about 65 degrees to about 75 degrees withrespect to the central axis.

Clause 41. The docking device of any of Clauses 23-40, wherein thearcuate body extends about a central axis, and wherein the needle axisextends at an angle of about 70 degrees with respect to the centralaxis.

Clause 42. The docking device of any of Clauses 23-41, wherein thearcuate body extends about a central axis, and wherein the needle axisextends toward the central axis.

Clause 43. The docking device of Clause 42, wherein the needle axisintersects with the central axis.

Clause 44. The docking device of any of Clauses 23-43, furthercomprising an alignment aperture extending through the body from anupper portion of the body to the eye-contacting portion.

Clause 45. The docking device of Clause 44, wherein the alignmentaperture defines a diameter of between about 8 mm to about 15 mm.

Clause 46. The docking device of Clause 44, wherein the alignmentaperture defines a diameter of between about 11.5 mm to about 12.5 mm.

Clause 47. The docking device of Clause 44, wherein the alignmentaperture defines a diameter of about 12 mm.

Clause 48. The docking device of any of Clauses 23-47, furthercomprising a bleb pocket adjacent to the needle port, the bleb pocketcomprising a concavity extending into the body from the eye-contactingportion toward an upper portion of the body.

Clause 49. The docking device of Clause 48, wherein the needle portcomprises an outlet, the outlet being disposed along the bleb pocket.

Clause 50. An intraocular inserter comprising a handle component and theinjector docking device of any of Clauses 1-49.

Clause 51. An injector docking device for placing an intraocular shuntinto an eye, the injector docking device comprising: a body comprisingfirst and second eye-contacting components coupled together via abridge, the first eye-contacting component spaced apart from the secondeye-contacting component, the first eye-contacting component comprisinga semicircular shape; and a needle support component coupled to thesecond eye-contacting component of the body, the needle supportcomponent comprising a needle port, the needle port defining a needleaxis extending through the second eye-contacting component toward thefirst eye-contacting component.

Clause 52. The docking device of Clause 51, wherein the needle axis doesnot intersect with the bridge.

Clause 53. The docking device of any of Clauses 51-52, wherein the firsteye-contacting component comprises a plurality of spikes for couplingthe injector docking device to the eye.

Clause 54. The docking device of any of Clauses 51-53, wherein the firsteye-contacting component comprises a channel for applying vacuumpressure to a surface of the eye.

Clause 55. The docking device of Clause 54, wherein the channel extendsalong a scleral contact surface of the first eye-contacting component.

Clause 56. The docking device of any of Clauses 54-55, wherein thechannel extends along a corneal contact surface of the firsteye-contacting component.

Clause 57. The docking device of any of Clauses 54-56, furthercomprising a vacuum port in fluid communication with the channel, thevacuum port extending from an upper portion of the body.

Clause 58. The docking device of any of Clauses 51-57, furthercomprising an alignment aperture extending through the bridge.

Clause 59. The docking device of any of Clauses 51-58, furthercomprising a bleb pocket in the second eye-contacting component adjacentto the needle port, the bleb pocket comprising a concavity extendinginto the second eye-contacting component.

Clause 60. The docking device of Clause 59, wherein the needle portcomprises an outlet, the outlet being disposed along the bleb pocket.

Clause 61. The docking device of any of Clauses 51-60, wherein theneedle support component comprises a shaft having the needle portextending therethrough, the needle port comprising a lumen within theshaft.

Clause 62. An intraocular inserter comprising a handle component and theinjector docking device of any of Clauses 51-61.

Clause 63. An injector docking device for placing an intraocular shuntinto an eye, the docking device comprising: a body comprising an annulareye-contacting component; and a needle support component coupled to theannular eye-contacting component of the body, the needle supportcomponent comprising a needle port, the needle port defining a needleaxis extending toward the annular eye-contacting component.

Clause 64. The docking device of Clause 63, wherein the annulareye-contacting component comprises a gap adjacent to the needle supportcomponent, the needle port extending to the gap toward a central axis ofthe annular eye-contacting component.

Clause 65. The docking device of any of Clauses 63-64, wherein theannular eye-contacting portion comprises a scleral contact surface and acorneal contact surface, the scleral contact surface defining a firstradius of curvature, the corneal contact surface defining a secondradius of curvature different than the first radius of curvature.

Clause 66. The docking device of Clause 65, wherein the first radius ofcurvature is greater than the second radius of curvature.

Clause 67. The docking device of any of Clauses 65-66, wherein thescleral contact surface and the corneal contact surface meet at a limbusridge, the limbus ridge comprising a circular protrusion extending in adirection away from the eye-contacting portion.

Clause 68. The docking device of any of Clauses 63-67, wherein theneedle support component comprises a shaft having the needle portextending therethrough, the needle port comprising a lumen within theshaft.

Clause 69. The docking device of any of Clauses 63-68, wherein theannular eye-contacting portion comprises an adhesion component forcoupling the injector docking device to the eye.

Clause 70. The docking device of Clause 69, wherein the adhesioncomponent comprises a plurality of spikes.

Clause 71. The docking device of any of Clauses 69-70, wherein theadhesion component comprises a channel for applying vacuum pressure to asurface of the eye.

Clause 72. The docking device of Clause 71, wherein the channel extendsalong a scleral contact surface of the body.

Clause 73. The docking device of any of Clauses 71-72, wherein thechannel extends along a corneal contact surface of the body.

Clause 74. The docking device of any of Clauses 71-73, furthercomprising a vacuum port in fluid communication with the channel, thevacuum port extending from an upper portion of the body.

Clause 75. The docking device of any of Clauses 63-74, wherein theannular eye-contacting component extends about a central axis, andwherein needle axis extends at an angle of between about 48 degrees toabout 98 degrees with respect to the central axis.

Clause 76. The docking device of any of Clauses 63-75, wherein theannular eye-contacting component extends about a central axis, andwherein the needle axis extends at an angle of between about 65 degreesto about 75 degrees with respect to the central axis.

Clause 77. The docking device of any of Clauses 63-76, wherein theannular eye-contacting component extends about a central axis, andwherein the needle axis extends at an angle of about 70 degrees withrespect to the central axis.

Clause 78. The docking device of any of Clauses 63-77, wherein theannular eye-contacting component extends about a central axis, andwherein the needle axis extends toward the central axis.

Clause 79. The docking device of Clause 63, wherein the needle axisintersects with the central axis.

Clause 80. The docking device of any of Clauses 63-79, furthercomprising an alignment aperture extending through the body from anupper portion of the body to the eye-contacting portion.

Clause 81. The docking device of Clause 80, wherein the alignmentaperture defines a diameter of between about 8 mm to about 15 mm.

Clause 82. The docking device of Clause 80, wherein the alignmentaperture defines a diameter of between about 11.5 mm to about 12.5 mm.

Clause 83. The docking device of Clause 80, wherein the alignmentaperture defines a diameter of about 12 mm.

Clause 84. The docking device of any of Clauses 63-83, furthercomprising a bleb pocket adjacent to the needle port, the bleb pocketcomprising a concavity extending into the body from the eye-contactingportion toward an upper portion of the body.

Clause 85. The docking device of Clause 84, wherein the needle portcomprises an outlet, the outlet being disposed along the bleb pocket.

Clause 86. An intraocular inserter comprising a handle component and theinjector docking device of any of Clauses 63-86.

Clause 87. An injector docking device for placing an intraocular shuntinto an eye, the injector docking device comprising: a body comprisingan elongate eye-contacting component having at least one tip portion forcontacting the eye; and a needle support component coupled to theelongate eye-contacting component of the body, the needle supportcomponent comprising a needle port, the needle port defining a needleaxis extending in a direction of the at least one tip portion elongateeye-contacting component.

Clause 88. The docking device of Clause 87, wherein the elongateeye-contacting component comprises a pair of prongs having proximal endscoupled to the needle support component, the proximal ends thereof beingspaced apart by a gap and having the needle port extending to the gap.

Clause 89. The docking device of Clause 88, wherein the pair of prongsdiverges to increase a size of the gap in a direction away from theneedle support component.

Clause 90. The docking device of any of Clauses 87-89, wherein theneedle support component comprises a shaft having the needle portextending therethrough, the needle port comprising a lumen within theshaft.

Clause 91. The docking device of any of Clauses 87-89, wherein theelongate eye-contacting portion comprises an adhesion component forcoupling the injector docking device to the eye.

Clause 92. The docking device of Clause 91, wherein the adhesioncomponent comprises a plurality of spikes.

Clause 93. The docking device of any of Clauses 91-92, wherein theadhesion component comprises a channel for applying vacuum pressure to asurface of the eye.

Clause 94. The docking device of Clause 93, wherein the channel extendsalong a scleral contact surface of the body.

Clause 95. The docking device of any of Clauses 93-94, wherein thechannel extends along a corneal contact surface of the body.

Clause 96. The docking device of any of Clauses 93-94, furthercomprising a vacuum port in fluid communication with the channel, thevacuum port extending from an upper portion of the body.

Clause 97. An intraocular inserter comprising a handle component and theinjector docking device of any of Clauses 87-96.

Clause 98. An inserter comprising the docking device of any of thepreceding Clauses, wherein the inserter and the docking device beingformed as a single, continuous piece of material.

Clause 99. An ab externo method of placing an intraocular shunt into aneye, the method comprising the steps of: determining an entry area belowa corneal limbus of an eye and a target outflow region; inserting ahollow shaft into the eye at the entry area toward an anterior chamberof the eye, the shaft configured to hold an intraocular shunt;positioning an inflow end of the shunt within the anterior chamber ofthe eye; while maintaining the shunt inflow end in the anterior chamber,removing the shaft from the eye to release the shunt; and verifyingplacement of an outflow end of the shunt within the target outflowregion.

Clause 100. The method of Clause 99, further comprising ballooning thetarget outflow region of the eye.

Clause 101. The method of Clause 100, wherein the ballooning comprisesforming a bleb in the target outflow region.

Clause 102. The method of Clause 101, further comprising massaging thebleb in a direction away from the corneal limbus to reposition theoutflow end of the shunt within the target outflow region.

Clause 103. The method of Clause 100, wherein the ballooning isperformed prior to inserting the hollow shaft into the eye.

Clause 104. The method of Clause 103, further comprising ballooning thetarget outflow region after the shunt is released to reinflate thetarget outflow region.

Clause 105. The method of Clause 100, wherein the ballooning isperformed after removing the shaft from the eye.

Clause 106. The method of any of Clauses 100-105, wherein the ballooningcomprises injecting an aqueous solution into the eye.

Clause 107. The method of any of Clauses 100-105, wherein the ballooningcomprises injecting a balanced salt solution, lidocaine, a healonsolution, or a viscoelastic into the eye.

Clause 108. The method of any of Clauses 99-107, wherein the positioningan inflow end of the shunt comprises advancing the shaft and the shunttogether in a pre-deployment configuration in which the inflow end ofthe shunt is positioned adjacent to a bevel of the shaft.

Clause 109. The method of any of Clauses 99-108, wherein the positioningan inflow end of the shunt comprises pushing the shunt within the shaftusing a plunger rod while maintaining a relative position between theshaft and the eye.

Clause 110. The method of any of Clauses 99-109, wherein the targetoutflow region comprises a subconjunctival space, a sub-Tenon's space,an intra-Tenon's space, an over-Tenon's space, a suprachoroidal space,an intrascleral space, Schlemm's canal, a vitreous space, an episcleralvein, a supraciliary space, or a suprascleral space.

Clause 111. The method of any of Clauses 99-110, further comprising:positioning an injector docking device on the eye, the injector dockingdevice comprising a needle port having a longitudinal axis; andorienting the needle port longitudinal axis to intersect with the entryarea and extend toward the anterior chamber.

Clause 112. The method of Clause 111, wherein the injector dockingdevice comprises a vacuum pocket on an eye-contacting surface thereof,the method further comprising applying suction between the injectordocking device and the eye via the vacuum pocket to removably couple theinjector docking device to the eye.

Clause 113. The method of any of Clauses 111-112, further comprisingremovably coupling the injector docking device to the eye via frictionalor mechanical engagement.

Clause 114. The method of Clause 113, wherein the injector dockingdevice comprises a plurality of spikes on an eye-contacting surfacethereof, the method further comprising engaging the plurality of spikeswith conjunctiva of the eye.

Clause 115. The method of any of Clauses 111-114, wherein the insertingthe hollow shaft comprises inserting the hollow shaft into the needleport and advancing the shaft through the needle port into the eye viathe entry area toward the anterior chamber.

Clause 116. The method of any of Clauses 111-115, wherein the injectordocking device comprises a bleb pocket adjacent to the needle port, themethod further comprising positioning the bleb pocket over a balloonedportion of the target outflow region.

Clause 117. The method of Clause 116, further comprising, beforepositioning the injector docking device on the eye, ballooning thetarget outflow region of the eye.

Clause 118. The method of Clause 111, wherein the injector dockingdevice comprises an eye-contacting portion having a half-ring component,wherein the positioning comprises positioning the half-ring componentagainst the eye.

Clause 119. The method of Clause 118, wherein the positioning comprisespositioning the half-ring component adjacent to the corneal limbus.

Clause 120. The method of any of Clauses 118-119, wherein thepositioning comprises positioning the half-ring component in a locationopposite the target outflow region along the corneal limbus.

Clause 121. The method of any of Clauses 118-120, wherein theeye-contacting portion further comprises an abutment portion, spacedapart from the half-ring component, the method further comprisingpositioning the abutment portion against the eye.

Clause 122. The method of Clause 121, wherein the positioning comprisespositioning the abutment portion adjacent to the target outflow region.

Clause 123. The method of Clause 121, wherein the positioning comprisespositioning the half-ring component against the eye adjacent to thecorneal limbus to provide an initial alignment of the hollow shaft, and,after achieving an initial alignment, moving the abutment portion intocontact with the eye adjacent the target outflow region, therebyinserting the hollow shaft into the eye at the entry area.

Clause 124. The method of any of Clauses 118-123, wherein the half-ringcomponent comprises a vacuum pocket, the method further comprisingapplying suction between the half-ring component and the eye via thevacuum pocket to removably couple the injector docking device to theeye.

Clause 125. The method of Clause 111, wherein the injector dockingdevice comprises a ring-shaped structure having an eye-contactingsurface configured to contact the eye, the method further comprisingpositioning the ring-shaped structure to place the eye-contactingsurface against the eye.

Clause 126. The method of Clause 125, wherein the eye-contacting surfaceis positioned adjacent to the corneal limbus.

Clause 127. The method of Clause 125, wherein the eye-contacting surfaceis extends along a majority of the corneal limbus.

Clause 128. The method of any of Clauses 125-127, wherein thering-shaped structure comprises a vacuum pocket, the method furthercomprising applying suction between the ring-shaped structure and theeye via the vacuum pocket to removably couple the injector dockingdevice to the eye.

Clause 129. The method of Clause 111, wherein the injector dockingdevice comprises a pair of prongs extending therefrom, the methodcomprising positioning tip portions of the prongs in contact with theeye to facilitate alignment of the needle port longitudinal axisrelative to the entry area.

Clause 130. The method of Clause 129, wherein the positioning comprisespositioning the prong tip portions against the corneal limbus of theeye.

Clause 131. The method of Clause 129, wherein the positioning comprisespositioning the prong tip portions against the eye adjacent to thecorneal limbus.

Clause 132. An ab externo method of placing an intraocular shunt into aneye, the method comprising the steps of: ballooning a target outflowregion within an eye; positioning an injector docking device, having aneedle port, against the eye, the needle port being aligned with thetarget outflow region; inserting a hollow shaft through the needle portto align the hollow shaft with the target outflow region, the hollowshaft housing an intraocular shunt therein; advancing the hollow shaftinto the eye toward an anterior chamber of the eye; positioning aninflow end of the shunt within the anterior chamber of the eye and anoutflow end of the shunt within the target outflow region; and whilemaintaining the longitudinal position of the shunt relative to the eye,removing the shaft from the eye to release the shunt.

Clause 133. The method of Clause 132, wherein the positioning theinjector docking device comprises aligning a longitudinal axis of theneedle port with the target outflow region.

Clause 134. The method of any of Clauses 132-133, wherein the ballooningcomprises forming a bleb in the target outflow region.

Clause 135. The method of Clause 134, further comprising after removingthe shaft from the eye, massaging the bleb in a direction away from thecorneal limbus to reposition the outflow end of the shunt within thetarget outflow region.

Clause 136. The method of any of Clauses 132-135, wherein the ballooningis performed prior to inserting the hollow shaft into the eye.

Clause 137. The method of any of Clauses 132-136, further comprisingballooning the target outflow region after the shunt is released toreinflate the target outflow region.

Clause 138. The method of any of Clauses 132-137, wherein the ballooningis performed after removing the shaft from the eye.

Clause 139. The method of any of Clauses 132-138, wherein the ballooningcomprises injecting an aqueous solution into the eye.

Clause 140. The method of any of Clauses 132-139, wherein the ballooningcomprises injecting a balanced salt solution, lidocaine, a healonsolution, or a viscoelastic into the eye.

Clause 141. The method of any of Clauses 132-140, wherein thepositioning an inflow end of the shunt comprises advancing the shaft andthe shunt together in a pre-deployment configuration in which the inflowend of the shunt is positioned adjacent to a bevel of the shaft.

Clause 142. The method of any of Clauses 132-140, wherein thepositioning an inflow end of the shunt comprises pushing the shuntwithin the shaft using a plunger rod while maintaining a relativeposition between the shaft and the eye.

Clause 143. The method of any of Clauses 132-142, wherein the targetoutflow region comprises a subconjunctival space, a sub-Tenon's space,an intra-Tenon's space, an over-Tenon's space, a suprachoroidal space,an intrascleral space, Schlemm's canal, a vitreous space, an episcleralvein, a supraciliary space, or a suprascleral space.

Clause 144. The method of any of Clauses 132-143, wherein the injectordocking device comprises a vacuum pocket on an eye-contacting surfacethereof, the method further comprising applying suction between theinjector docking device and the eye via the vacuum pocket to removablycouple the injector docking device to the eye.

Clause 145. The method of any of Clauses 132-144, further comprisingremovably coupling the injector docking device to the eye via frictionalor mechanical engagement.

Clause 146. The method of Clause 145, wherein the injector dockingdevice comprises a plurality of spikes on an eye-contacting surfacethereof, the method further comprising engaging the plurality of spikeswith conjunctiva of the eye.

Clause 147. The method of any of Clauses 132-146, wherein the injectordocking device comprises a bleb pocket adjacent to the needle port, themethod further comprising positioning the bleb pocket over a balloonedportion of the target outflow region.

Clause 148. The method of Clause 147, wherein a longitudinal axis of theneedle port intersects with the bleb pocket.

Clause 149. The method of any of Clauses 132-148, wherein the injectordocking device comprises an eye-contacting portion having a half-ringcomponent, wherein the positioning the injector docking device comprisespositioning the half-ring component against the eye.

Clause 150. The method of Clause 149, wherein the positioning theinjector docking device comprises positioning the half-ring componentadjacent to the corneal limbus.

Clause 151. The method of any of Clauses 149-151, wherein thepositioning the injector docking device comprises positioning thehalf-ring component in a location opposite the target outflow regionalong the corneal limbus.

Clause 152. The method of any of Clauses 149-152, wherein theeye-contacting portion further comprises an abutment portion, spacedapart from the half-ring component, the method further comprisingpositioning the abutment portion against the eye.

Clause 153. The method of Clause 152, wherein the positioning theabutment portion comprises positioning the abutment portion adjacent tothe target outflow region.

Clause 154. The method of any of Clauses 152-153, wherein thepositioning the abutment portion comprises positioning the half-ringcomponent against the eye adjacent to the corneal limbus to provide aninitial alignment of the hollow shaft, and, after achieving an initialalignment, moving the abutment portion into contact with the eyeadjacent the target outflow region, thereby inserting the hollow shaftinto the eye.

Clause 155. The method of any of Clauses 149-154, wherein the half-ringcomponent comprises a vacuum pocket, the method further comprisingapplying suction between the half-ring component and the eye via thevacuum pocket to removably couple the injector docking device to theeye.

Clause 156. The method of any of Clauses 132-148, wherein the injectordocking device comprises a ring-shaped structure having aneye-contacting surface configured to contact the eye, wherein thepositioning the injector docking device comprises positioning theeye-contacting surface of the ring-shaped structure against the eye.

Clause 157. The method of Clause 156, wherein the eye-contacting surfaceis positioned adjacent to the corneal limbus.

Clause 158. The method of any of Clauses 156-157, wherein theeye-contacting surface is extends along a majority of the corneallimbus.

Clause 159. The method of any of Clauses 156-158, wherein thering-shaped structure comprises a vacuum pocket, the method furthercomprising applying suction between the ring-shaped structure and theeye via the vacuum pocket to removably couple the injector dockingdevice to the eye.

Clause 160. The method of any of Clauses 132-148, wherein the injectordocking device comprises a pair of prongs extending therefrom, whereinthe positioning the injector docking device comprises positioning tipportions of the prongs in contact with the eye to facilitate alignmentof the needle port longitudinal axis relative to the target outflowregion.

Clause 161. The method of Clause 160, wherein the positioning theinjector docking device comprises positioning the prong tip portionsagainst the corneal limbus of the eye.

Clause 162. The method of Clause 160, wherein the positioning theinjector docking device comprises positioning the prong tip portionsagainst the eye adjacent to the corneal limbus.

Clause 163. An ab externo method of placing an intraocular shunt into aneye, the method comprising the steps of: inserting a hollow shaft intoan eye below a corneal limbus of the eye, the shaft housing anintraocular shunt; positioning an inflow end of the shunt within ananterior chamber of the eye; while maintaining the shunt inflow end inthe anterior chamber, removing the shaft from the eye to release theshunt; and ballooning a target outflow region of the eye, the targetoutflow region being adjacent to an outflow end of the shunt, whereinthe ballooning repositions the outflow end of the shunt within the eyein the target outflow region.

Clause 164. The method of Clause 163, wherein the ballooning comprisesforming a bleb in the target outflow region.

Clause 165. The method of Clause 164, further comprising massaging thebleb in a direction away from the corneal limbus to reposition theoutflow end of the shunt within the target outflow region.

Clause 166. The method of any of Clauses 163-165, wherein the ballooningcomprises injecting an aqueous solution into the eye.

Clause 167. The method of any of Clauses 163-166, wherein the ballooningcomprises injecting a balanced salt solution, lidocaine, a healonsolution, or a viscoelastic into the eye.

Clause 168. The method of any of Clauses 163-167, wherein thepositioning an inflow end of the shunt comprises advancing the shaft andthe shunt together in a pre-deployment configuration in which the inflowend of the shunt is positioned adjacent to a bevel of the shaft.

Clause 169. The method of any of Clauses 163-168, wherein thepositioning an inflow end of the shunt comprises pushing the shuntwithin the shaft using a plunger rod while maintaining a relativeposition between the shaft and the eye.

Clause 170. The method of any of Clauses 163-169, wherein the targetoutflow region comprises a subconjunctival space, a sub-Tenon's space,an intra-Tenon's space, an over-Tenon's space, a suprachoroidal space,an intrascleral space, Schlemm's canal, a vitreous space, an episcleralvein, a supraciliary space, or a suprascleral space.

Clause 171. The method of any of Clauses 163-170, further comprising:positioning an injector docking device on the eye, the injector dockingdevice comprising a needle port having a longitudinal axis; andorienting the needle port longitudinal axis to intersect with the targetoutflow area and extend toward the anterior chamber.

Clause 172. The method of Clause 171, wherein the injector dockingdevice comprises a vacuum pocket on an eye-contacting surface thereof,the method further comprising applying suction between the injectordocking device and the eye via the vacuum pocket to removably couple theinjector docking device to the eye.

Clause 173. The method of any of Clauses 171-172, further comprisingremovably coupling the injector docking device to the eye via frictionalor mechanical engagement.

Clause 174. The method of Clause 173, wherein the injector dockingdevice comprises a plurality of spikes on an eye-contacting surfacethereof, the method further comprising engaging the plurality of spikeswith conjunctiva of the eye.

Clause 175. The method of any of Clauses 171-174, wherein the insertingthe hollow shaft comprises inserting the hollow shaft into the needleport and advancing the shaft through the needle port into the eye viathe target outflow area toward the anterior chamber.

Clause 176. The method of any of Clauses 171-175, wherein the injectordocking device comprises an eye-contacting portion having a half-ringcomponent, wherein the positioning comprises positioning the half-ringcomponent against the eye.

Clause 177. The method of Clause 176, wherein the positioning comprisespositioning the half-ring component adjacent to the corneal limbus.

Clause 178. The method of any of Clauses 176-178, wherein thepositioning comprises positioning the half-ring component in a locationopposite the target outflow region along the corneal limbus.

Clause 179. The method of any of Clauses 176-179, wherein theeye-contacting portion further comprises an abutment portion, spacedapart from the half-ring component, the method further comprisingpositioning the abutment portion against the eye.

Clause 180. The method of Clause 179, wherein the positioning comprisespositioning the abutment portion adjacent to the target outflow region.

Clause 181. The method of any of Clauses 179-180, wherein thepositioning comprises positioning the half-ring component against theeye adjacent to the corneal limbus to provide an initial alignment ofthe hollow shaft, and, after achieving an initial alignment, moving theabutment portion into contact with the eye adjacent the target outflowregion, thereby inserting the hollow shaft into the eye.

Clause 182. The method of any of Clauses 176-181, wherein the half-ringcomponent comprises a vacuum pocket, the method further comprisingapplying suction between the half-ring component and the eye via thevacuum pocket to removably couple the injector docking device to theeye.

Clause 183. The method of any of Clauses 171-175, wherein the injectordocking device comprises a ring-shaped structure having aneye-contacting surface configured to contact the eye, the method furthercomprising positioning the ring-shaped structure to place theeye-contacting surface against the eye.

Clause 184. The method of Clause 183, wherein the eye-contacting surfaceis positioned adjacent to the corneal limbus.

Clause 185. The method of any of Clauses 183-184, wherein theeye-contacting surface is extends along a majority of the corneallimbus.

Clause 186. The method of any of Clauses 183-185, wherein thering-shaped structure comprises a vacuum pocket, the method furthercomprising applying suction between the ring-shaped structure and theeye via the vacuum pocket to removably couple the injector dockingdevice to the eye.

Clause 187. The method of any of Clauses 171-175, wherein the injectordocking device comprises a pair of prongs extending therefrom, themethod comprising positioning tip portions of the prongs in contact withthe eye to facilitate alignment of the needle port longitudinal axisrelative to the target outflow area.

Clause 188. The method of Clause 187, wherein the positioning comprisespositioning the prong tip portions against the corneal limbus of theeye.

Clause 189. The method of any of Clauses 187-188, wherein thepositioning comprises positioning the prong tip portions against the eyeadjacent to the corneal limbus.

Clause 190. An ab externo method of placing an intraocular shunt in aneye, the method comprising any steps of the methods of the precedingClauses and using any of the inserters, components, or devices of thepreceding Clauses.

Clause 191. A method of placing an intraocular shunt in the eye, themethod comprising any steps of the methods of the preceding Clauses andwherein the shunt comprises a pharmaceutical or biological agent as acoating on an exterior surface of the shunt.

Clause 192. A method of placing an intraocular shunt in the eye, themethod comprising any steps of the methods of the preceding Clauses andwherein the shunt comprises a pharmaceutical or biological agentcomprises a coating on an interior surface of the shunt.

Clause 193. A method of placing an intraocular shunt in the eye, themethod comprising any steps of the methods of the preceding Clauses andwherein a portion of the shunt is impregnated with a pharmaceutical orbiological agent.

Clause 194. A method of placing an intraocular shunt in the eye, themethod comprising any steps of the methods of the preceding Clauses andwherein the shunt comprises a time-release pharmaceutical or biologicalagent.

Clause 195. An injector docking device comprising any of the features ofthe inserters, components, or devices of the preceding Clauses.

Clause 196. An inserter for placing an intraocular shunt in an eye,comprising any of the features of the inserters, components, or devicesof the preceding Clauses.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method Clauses presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

While certain aspects and embodiments of the inventions have beendescribed, these have been presented by way of example only, and are notintended to limit the scope of the inventions. Indeed, the novel methodsand systems described herein may be embodied in a variety of other formswithout departing from the spirit thereof. The accompanying claims andtheir equivalents are intended to cover such forms or modifications aswould fall within the scope and spirit of the inventions.

What is claimed is:
 1. An ab externo method of placing an intraocularshunt into an eye, the method comprising the steps of: determining anentry area below a corneal limbus of an eye and a target outflow region;inserting a hollow shaft into the eye at the entry area toward ananterior chamber of the eye, the shaft carrying the intraocular shunttherein; positioning an inflow end of the shunt within the anteriorchamber of the eye; while maintaining the shunt inflow end in theanterior chamber, removing the shaft from the eye to release the shunt;repositioning an outflow end of the shunt within the target outflowregion; and verifying placement of the outflow end of the shunt withinthe target outflow region; wherein the method is performed withoutmaking a scleral flap or otherwise requiring a conjunctival dissection.2. The method of claim 1, further comprising: positioning an injectordocking device on the eye, the injector docking device comprising aneedle port having a longitudinal axis; and orienting the needle portlongitudinal axis to intersect with the entry area and extend toward theanterior chamber.
 3. The method of claim 2, wherein the injector dockingdevice comprises a vacuum pocket on an eye-contacting surface thereof,the method further comprising applying suction between the injectordocking device and the eye via the vacuum pocket to removably couple theinjector docking device to the eye.
 4. The method of claim 2, whereinthe inserting the hollow shaft comprises inserting the hollow shaft intothe needle port and advancing the shaft through the needle port into theeye via the entry area toward the anterior chamber.
 5. The method ofclaim 2, wherein the injector docking device comprises an eye-contactingportion having a concave surface, wherein the positioning comprisespositioning the concave surface against the eye.
 6. The method of claim5, wherein the positioning comprises positioning the concave surfaceadjacent to the corneal limbus.
 7. The method of claim 5, wherein thepositioning comprises positioning the concave surface component in alocation opposite the target outflow region along the corneal limbus. 8.The method of claim 2, wherein the injector docking device comprises aring-shaped structure having an eye-contacting surface configured tocontact the eye, the method further comprising positioning thering-shaped structure to place the eye-contacting surface against theeye.
 9. The method of claim 2, wherein positioning the injector dockingdevice comprises positioning prong tip portions of the injector dockingdevice against the corneal limbus of the eye.
 10. The method of claim 1,wherein the method is performed without using an injector dockingdevice.
 11. An ab externo method of placing an intraocular shunt into aneye, the method comprising the steps of: positioning an injector dockingdevice, having a needle port, against the eye, the needle port beingaligned with a target outflow region; advancing a hollow shaft throughthe needle port with the hollow shaft aligned with the target outflowregion, the hollow shaft housing the intraocular shunt therein;advancing the hollow shaft into the eye toward an anterior chamber ofthe eye; positioning an inflow end of the shunt within the anteriorchamber of the eye; verifying placement of an outflow end of the shuntwithin the target outflow region; while maintaining a longitudinalposition of the shunt relative to the eye, removing the shaft from theeye to release the shunt; and repositioning the outflow end of the shuntwithin the target outflow region; wherein the method is performedwithout making a scleral flap or otherwise requiring a conjunctivaldissection.
 12. The method of claim 11, wherein the positioning theinjector docking device comprises aligning a longitudinal axis of theneedle port with the target outflow region.
 13. The method of claim 11,wherein the advancing the hollow shaft comprises advancing a sleeve ofan inserter, separate from the injector docking device and including thehollow shaft, into the needle port to introduce the hollow shaft intothe needle port in a direction toward the target outflow region.
 14. Themethod of claim 11, wherein the injector docking device extends from anend portion of an inserter, the injector docking device and the inserterbeing formed from a single, continuous housing, the hollow shaftextending from the inserter through the needle port.
 15. The method ofclaim 11, wherein the injector docking device comprises aneye-contacting portion having a concave surface, wherein the positioningcomprises positioning the concave surface against the eye.
 16. Themethod of claim 15, wherein the positioning comprises positioning theconcave surface adjacent to the corneal limbus.
 17. An ab externo methodof placing an intraocular shunt into an eye, the method comprising thesteps of: determining an entry area below a corneal limbus of an eye anda target outflow region; inserting a hollow shaft into the eye at theentry area toward an anterior chamber of the eye, the shaft carrying theintraocular shunt therein; positioning an inflow end of the shunt withinthe anterior chamber of the eye; while maintaining the shunt inflow endin the anterior chamber, removing the shaft from the eye to release theshunt; repositioning an outflow end of the shunt within the targetoutflow region; and verifying placement of the outflow end of the shuntwithin the target outflow region, wherein the target outflow regioncomprises an intra-Tenon's adhesion space of the eye.
 18. The method ofclaim 17, wherein Tenon adhesions of the intra-Tenon's adhesion spaceremain intact.
 19. The method of claim 17, further comprisingpositioning an injector docking device on the eye, the injector dockingdevice comprising an eye-contacting portion having a concave surface,wherein the positioning comprises positioning the concave surfaceagainst the eye.
 20. An ab externo method of placing an intraocularshunt into an eye, the method comprising the steps of: positioning aninjector docking device, having a needle port, against the eye, theneedle port being aligned with a target outflow region; advancing ahollow shaft through the needle port with the hollow shaft aligned withthe target outflow region, the hollow shaft housing the intraocularshunt therein; advancing the hollow shaft into the eye toward ananterior chamber of the eye; positioning an inflow end of the shuntwithin the anterior chamber of the eye; verifying placement of anoutflow end of the shunt within the target outflow region; whilemaintaining a longitudinal position of the shunt relative to the eye,removing the shaft from the eye to release the shunt; and repositioningthe outflow end of the shunt within the target outflow region, whereinthe target outflow region comprises an intra-Tenon's adhesion space ofthe eye.
 21. The method of claim 20, wherein Tenon adhesions of theintra-Tenon's adhesion space remain intact.
 22. The method of claim 20,wherein the injector docking device comprises an eye-contacting portionhaving a concave surface, wherein the positioning comprises positioningthe concave surface against the eye.